business plan for a pharmaceutical manufacturing company

Pharmaceutical Business Plan Template

Written by Dave Lavinsky

Pharmaceutical Business Plan

Over the past 20+ years, we have helped over 500 entrepreneurs and business owners create business plans to start and grow their pharmaceutical companies.

If you’re unfamiliar with creating a pharmaceutical business plan, you may think creating one will be a time-consuming and frustrating process. For most entrepreneurs it is, but for you, it won’t be since we’re here to help. We have the experience, resources, and knowledge to help you create a great business plan.

In this article, you will learn some background information on why business planning is important. Then, you will learn how to write a pharmaceutical business plan step-by-step so you can create your plan today.

Download our Ultimate Business Plan Template here >

What is a Pharmaceutical Business Plan?

A business plan provides a snapshot of your pharmaceutical business as it stands today, and lays out your growth plan for the next five years. It explains your business goals and your strategies for reaching them. It also includes market research to support your plans.

Why You Need a Business Plan for a Pharmaceutical Company

If you’re looking to start a pharmaceutical business or grow your existing company, you need a business plan. A business plan will help you raise funding, if needed, and plan out the growth of your pharmaceutical company to improve your chances of success. Your business plan is a living document that should be updated annually as your company grows and changes.

Sources of Funding for Pharmaceutical Businesses

With regards to funding, the main sources of funding for a pharmaceutical business are personal savings, credit cards, bank loans, and angel investors. When it comes to bank loans, banks will want to review your business plan and gain confidence that you will be able to repay your loan and interest. To acquire this confidence, the loan officer will not only want to ensure that your financials are reasonable, but they will also want to see a professional plan. Such a plan will give them the confidence that you can successfully and professionally operate a business. Personal savings and bank loans are the most common funding paths for pharmaceutical businesses.

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How to write a business plan for a pharmaceutical company.

If you want to start a pharmaceutical company or expand your current one, you need a business plan. The guide below details the necessary information for how to write each essential component of your pharmaceutical business plan.

Executive Summary

Your executive summary provides an introduction to your business plan, but it is normally the last section you write because it provides a summary of each key section of your plan.

The goal of your executive summary is to quickly engage the reader. Explain to them the kind of pharmaceutical business you are running and the status. For example, are you a startup, do you have a company that you would like to grow, or are you operating pharmaceutical companies in multiple markets?

Next, provide an overview of each of the subsequent sections of your plan.

• Give a brief overview of the pharmaceutical industry.
• Discuss the type of pharmaceutical business you are operating.
• Detail your direct competitors. Give an overview of your target customers.
• Provide a snapshot of your marketing strategy. Identify the key members of your team.
• Offer an overview of your financial plan.

Company Overview

In your company overview, you will detail the type of pharmaceutical company you are operating.

For example, you might specialize in one of the following types of pharmaceutical businesses:

• Generic Pharmaceutical Manufacturing : this type of pharmaceutical business develops prescription or over-the-counter drugs products that do not have patent protection.
• Vitamin & Supplement Manufacturing: this type of pharmaceutical company primarily develops products that contain ingredients intended to supplement the diet.
• Brand Name Pharmaceutical Manufacturing: this type of pharmaceutical business engages in significant research and development of patent-protected prescription and over-the-counter medications.

In addition to explaining the type of pharmaceutical business you will operate, the company overview needs to provide background on the business.

Include answers to questions such as:

• When and why did you start the business?
• What milestones have you achieved to date? Milestones could include the number of patents awarded, the extent of your product portfolio, reaching X number of distributors under contract, etc.
• Your legal business Are you incorporated as an S-Corp? An LLC? A sole proprietorship? Explain your legal structure here.

Industry Analysis

In your industry or market analysis, you need to provide an overview of the pharmaceutical industry.

While this may seem unnecessary, it serves multiple purposes.

First, researching the pharmaceutical industry educates you. It helps you understand the market in which you are operating.

Secondly, market research can improve your marketing strategy, particularly if your analysis identifies market trends.

The third reason is to prove to readers that you are an expert in your industry. By conducting the research and presenting it in your plan, you achieve just that.

The following questions should be answered in the industry analysis section:

• How big is the pharmaceutical industry (in dollars)?
• Is the market declining or increasing?
• Who are the key competitors in the market?
• Who are the key suppliers in the market?
• What trends are affecting the industry?
• What is the industry’s growth forecast over the next 5 – 10 years?
• What is the relevant market size? That is, how big is the potential target market for your pharmaceutical company? You can extrapolate such a figure by assessing the size of the market in the entire country and then applying that figure to your local population.

Customer Analysis

The customer analysis section of your business plan must detail the customers you serve and/or expect to serve.

The following are examples of customer segments: healthcare providers, chain pharmacies, independent retailers, and consumers.

As you can imagine, the customer segment(s) you choose will have a great impact on the type of pharmaceutical business you operate. Clearly, individuals would respond to different marketing promotions than hospitals, for example.

Try to break out your target customers in terms of their demographic and psychographic profiles. With regards to demographics, including a discussion of the ages, genders, locations, and income levels of the potential customers you seek to serve.

Psychographic profiles explain the wants and needs of your target customers. The more you can recognize and define these needs, the better you will do in attracting and retaining your customers.

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Competitive Analysis

Your competitive analysis should identify the indirect and direct competitors your business faces and then focus on the latter.

Direct competitors are other pharmaceutical businesses.

Indirect competitors are other options that customers have to purchase from that aren’t directly competing with your product or service. This includes imported alternatives, herbal remedies, or customers’ nutritional self-care. You need to mention such competition as well.

For each such competitor, provide an overview of their business and document their strengths and weaknesses. Unless you once worked at your competitors’ businesses, it will be impossible to know everything about them. But you should be able to find out key things about them such as

• What types of products do they manufacture?
• What are their research and development capabilities?
• What is their pricing (premium, low, etc.)?
• What are they good at?
• What are their weaknesses?

With regards to the last two questions, think about your answers from the customers’ perspective. And don’t be afraid to ask your competitors’ customers what they like most and least about them.

The final part of your competitive analysis section is to document your areas of competitive advantage. For example:

• Will you provide product development?
• Will you offer products or services that your competition doesn’t?
• Will you provide better customer service?
• Will you offer better pricing?

Think about ways you will outperform your competition and document them in this section of your plan.  

Marketing Plan

Traditionally, a marketing plan includes the four P’s: Product, Price, Place, and Promotion. For a pharmaceutical company, your marketing strategy should include the following:

Product : In the product section, you should reiterate the type of pharmaceutical business that you documented in your company overview. Then, detail the specific products or services you will be offering. For example, will you manufacture patent-protected prescription medications, or a range of vitamins?

Price : Document the prices you will offer and how they compare to your competitors. Essentially in the product and price sub-sections of your plan, you are presenting the products and/or services you offer and their prices.

Place : Place refers to the site of your pharmaceutical business. Document where your company is situated and mention how the site will impact your success. For example, is your pharmaceutical company located in an industrial district, near a major medical and/or scientific hub, or near input markets? Discuss how your site might be the ideal location for your customers.

Promotions : The final part of your pharmaceutical marketing plan is where you will document how you will drive potential customers to your location(s). The following are some promotional methods you might consider:

• Advertise in local papers, radio stations and/or magazines
• Advertise in trade publications
• Reach out to websites
• Distribute flyers
• Engage in email marketing
• Advertise on social media platforms
• Improve the SEO (search engine optimization) on your website for targeted keywords

Operations Plan

While the earlier sections of your business plan explained your goals, your operations plan describes how you will meet them. Your operations plan should have two distinct sections as follows.

Everyday short-term processes include all of the tasks involved in running your pharmaceutical company, including meeting with potential customers, creating and distributing product information, developing and manufacturing products, etc.

Long-term goals are the milestones you hope to achieve. These could include the dates when you expect to produce your Xth product, or when you hope to reach $X in revenue. It could also be when you expect to expand your pharmaceutical business to a new city.  

Management Team

To demonstrate your pharmaceutical company’s potential to succeed, a strong management team is essential. Highlight your key players’ backgrounds, emphasizing those skills and experiences that prove their ability to grow a company.

Ideally, you and/or your team members have direct experience in managing pharmaceutical businesses. If so, highlight this experience and expertise. But also highlight any experience that you think will help your business succeed.

If your team is lacking, consider assembling an advisory board. An advisory board would include 2 to 8 individuals who would act as mentors to your business. They would help answer questions and provide strategic guidance. If needed, look for advisory board members with experience in managing a pharmaceutical business or successfully running a R&D company.  

Financial Plan

Your financial plan should include your 5-year financial statement broken out both monthly or quarterly for the first year and then annually. Your financial statements include your income statement, balance sheet, and cash flow statements.

Income Statement

An income statement is more commonly called a Profit and Loss statement or P&L. It shows your revenue and then subtracts your costs to show whether you turned a profit or not.

In developing your income statement, you need to devise assumptions including your sales projections. For example, will you manufacture a line of general sales products, or will you specialize in manufacturing controlled drugs? And will sales grow by 2% or 10% per year? As you can imagine, your choice of assumptions will greatly impact the financial forecasts for your business. As much as possible, conduct research to try to root your assumptions in reality.

Balance Sheets

Balance sheets show your assets and liabilities. While balance sheets can include much information, try to simplify them to the key items you need to know about. For instance, if you spend $50,000 on building out your pharmaceutical company, this will not give you immediate profits. Rather it is an asset that will hopefully help you generate profits for years to come. Likewise, if a lender writes you a check for $50,000, you don’t need to pay it back immediately. Rather, that is a liability you will pay back over time.

Cash Flow Statement

Your cash flow statement will help determine how much money you need to start or grow your business, and ensure you never run out of money. What most entrepreneurs and business owners don’t realize is that you can turn a profit but run out of money and go bankrupt.

When creating your Income Statement and Balance Sheets be sure to include several of the key costs needed in starting or growing a pharmaceutical company:

• Cost of equipment and supplies
• Payroll or salaries paid to staff
• Business insurance
• Other start-up expenses (if you’re a new business) like legal expenses, permits, computer software, and equipment

Attach your full financial projections in the appendix of your plan along with any supporting documents that make your plan more compelling. For example, you might include your facility blueprint or a list of products you manufacture.  

Writing a business plan for your pharmaceutical business is a worthwhile endeavor. If you follow the template above, by the time you are done, you will truly be an expert. You will understand the pharmaceutical company industry, your competition, and your customers. You will develop a marketing strategy and will understand what it takes to launch and grow a successful pharmaceutical company.

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Other Helpful Business Plan Articles & Templates

Business Plan Template for Pharmaceutical Companies

• Great for beginners
• Ready-to-use, fully customizable Subcategory
• Get started in seconds

Securing funding and navigating the highly regulated pharmaceutical industry can be a daunting task for any company. But with ClickUp's Business Plan Template for Pharmaceutical Companies, you can streamline the process and increase your chances of success!

Our template provides you with all the essential elements you need to create a comprehensive and compelling business plan, including:

• Strategic goals to guide your company's growth and development
• Financial projections to showcase the potential profitability of your products and services
• Market analysis to identify key trends, competitors, and target markets
• Operational plans to outline your manufacturing, distribution, and regulatory strategies

Don't miss out on the opportunity to attract investors and secure funding for your pharmaceutical company. Get started with ClickUp's Business Plan Template today and take your business to new heights!

Business Plan Template for Pharmaceutical Companies Benefits

A business plan template designed specifically for pharmaceutical companies offers a range of benefits, including:

• Streamlining the process of creating a comprehensive business plan, saving time and effort
• Providing a clear structure and framework for organizing key information and data
• Ensuring all critical components of a pharmaceutical business plan are included, such as market analysis, competitive analysis, and regulatory compliance
• Presenting a professional and polished document that is attractive to investors and lenders
• Helping pharmaceutical companies articulate their unique value proposition and competitive advantage in the market
• Guiding strategic decision-making and long-term planning for growth and success in the industry.

Main Elements of Pharmaceutical Companies Business Plan Template

ClickUp's Business Plan Template for Pharmaceutical Companies provides a comprehensive solution for creating and managing your pharmaceutical business plan. Here are the main elements of this template:

• Custom Statuses: Keep track of the progress of each section of your business plan with statuses like Complete, In Progress, Needs Revision, and To Do.
• Custom Fields: Add important details to your business plan, such as Reference, Approved, and Section, to ensure accurate documentation and easy reference.
• Custom Views: Access different views, including Topics, Status, Timeline, Business Plan, and Getting Started Guide, to organize and visualize your business plan from different perspectives.
• Collaboration Tools: Utilize ClickUp's collaboration features like comments, mentions, and task assignments to collaborate effectively with your team members and stakeholders.
• Document Management: Store and manage all relevant documents related to your business plan using ClickUp Docs, ensuring easy access and version control.

How To Use Business Plan Template for Pharmaceutical Companies

If you're in the pharmaceutical industry and need to create a business plan, the Business Plan Template for Pharmaceutical Companies in ClickUp can help you get started. Follow these five steps to develop a comprehensive plan for your company's success:

1. Company Overview

Begin by providing a clear and concise overview of your pharmaceutical company. Include details such as your mission statement, vision, values, and a brief history of your organization. Highlight your unique selling proposition and explain how your company stands out in the competitive pharmaceutical market.

Use the Docs feature in ClickUp to write a compelling company overview with all the necessary information.

2. Market Analysis

Conduct a thorough analysis of the pharmaceutical market to identify trends, opportunities, and potential challenges. Research your target audience, competitors, and industry regulations. Provide insights into market size, growth projections, and key market segments that you plan to target.

Utilize the Table view in ClickUp to organize and analyze your market research data effectively.

3. Product Portfolio

Outline your product portfolio and describe the pharmaceutical products or services you offer. Highlight their unique features, benefits, and potential impact on patients' lives. Discuss your research and development efforts, clinical trials, and any patents or intellectual property you have.

Create tasks in ClickUp to track your product development milestones and progress.

4. Marketing and Sales Strategy

Detail your marketing and sales strategies to reach your target audience and generate revenue. Identify your target market segments and outline your marketing channels, such as digital advertising, trade shows, or partnerships with healthcare providers. Define your pricing strategy, distribution channels, and sales forecasting.

Use the Gantt chart feature in ClickUp to visualize and track your marketing and sales activities over time.

5. Financial Projections

Provide financial projections that demonstrate the profitability and sustainability of your pharmaceutical company. Include a comprehensive analysis of your revenue streams, costs, and projected financial statements such as income statements, balance sheets, and cash flow statements. Consider factors such as research and development costs, manufacturing expenses, and pricing strategies.

Utilize the Dashboards feature in ClickUp to create visual representations of your financial data and track your progress towards financial goals.

By using the Business Plan Template for Pharmaceutical Companies in ClickUp and following these steps, you can create a comprehensive business plan that sets your pharmaceutical company up for success in the competitive industry.

Get Started with ClickUp’s Business Plan Template for Pharmaceutical Companies

Pharmaceutical companies can use the Business Plan Template for Pharmaceutical Companies in ClickUp to effectively outline their strategic goals and financial projections, as well as navigate the complex and highly regulated pharmaceutical industry.

First, hit “Add Template” to sign up for ClickUp and add the template to your Workspace. Make sure you designate which Space or location in your Workspace you’d like this template applied.

Next, invite relevant members or guests to your Workspace to start collaborating.

Now you can take advantage of the full potential of this template to create a comprehensive business plan:

• Use the Topics View to organize different sections of your business plan, such as market analysis, product development, and financial projections
• The Status View will help you track the progress of each section, with statuses like Complete, In Progress, Needs Revision, and To Do
• The Timeline View will allow you to set deadlines and milestones for each section of your business plan
• The Business Plan View provides a holistic overview of your entire plan, allowing you to easily navigate and make updates
• The Getting Started Guide View will provide step-by-step instructions on how to use the template and create an effective business plan
• Utilize custom fields like Reference, Approved, and Section to add additional information and categorize different sections of your plan
• Collaborate with team members to gather input, feedback, and revisions to ensure a comprehensive and well-rounded business plan
• Monitor and analyze the progress of each section to ensure your business plan is on track and meets the needs of investors and stakeholders.
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Step-by-Step Guide to Starting a Pharmaceutical Company

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Starting a pharmaceutical company is a challenging but potentially rewarding venture. This summary will provide an overview of key considerations in starting such a business.

Introduction:

Starting a pharmaceutical company is promising but demands substantial time, effort, and resources. Success hinges on market understanding, regulatory compliance, and effective business models. With dedication and knowledge, anyone can embark on this journey.

Thorough research is critical. Dive into the industry, study competitors, and grasp relevant regulations. Analyze market trends, technological advancements, and your competitors’ strengths and weaknesses.

Understanding Regulations:

Pharmaceutical businesses are heavily regulated. Comprehend FDA and local regulations, and consider seeking expert guidance. Stay updated on legal changes, maintain industry standards, and document procedures to avoid legal complications.

Business Model:

Selecting the right business model is crucial. Options include contract manufacturing, retail, and franchising. Each has pros and cons, and your choice should align with your goals, start-up capacity, and customer service strategy.

Launching a pharmaceutical business requires substantial capital for equipment, research, marketing, staffing, and more. Seek funding through government grants, investors, loans, or personal savings, considering tax implications and potential incentives.

Inventory and Supply Chain:

Manage inventory based on business size and product type. Storage conditions and transportation must align with product requirements. Establish efficient supply chains to ensure timely product turnover.

Distribution:

Effective distribution networks are essential for reaching customers. Decide on distribution methods, whether through wholesalers, retailers, or online sales. Choose experienced distributors and continuously evaluate and improve distribution channels.

Technology:

Technology plays a crucial role in pharmaceuticals. Automation enhances efficiency and reduces errors. Invest in secure data storage, cybersecurity, and customer interaction technologies, like websites and social media, to build trust and competitiveness.

Operations:

Operational processes are the backbone of any business. Develop efficient protocols for inventory, production, quality assurance, and regulatory compliance. Quality assurance is paramount in pharmaceuticals.

Prospecting Strategies:

Marketing in the pharmaceutical industry must comply with strict regulations. Consider online advertising, networking, print ads, direct mail, and conferences. Tailor strategies to your target audience and budget.

Insurance and Security:

Protect your business with adequate insurance coverage, considering your company’s size and activities. Implement security measures like surveillance, data encryption, and biometric technology to safeguard assets and sensitive information.

Conclusion:

Starting a pharmaceutical company is a complex but achievable endeavor with careful planning, adherence to regulations, robust business models, and the right technology. Building a reliable distribution network and marketing strategy are vital. Ensure safety and security with insurance and security protocols. Regular monitoring and adaptation are key to success in this dynamic industry. Good luck on your journey!

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Table of Contents

Introduction to Starting a Pharmaceutical Company

A pharmaceutical company can be an appealing business venture, as it can offer the potential of substantial revenue growth and a meaningful impact on people’s lives. There is no doubt that starting a pharmaceutical company requires a great deal of time, effort, and resources. However, with the right knowledge and dedication, starting a pharmaceutical company can be a rewarding experience.

It is important to have a thorough understanding of the market, regulations, and business models in order to be successful in this field. With the right combination of research, planning, and dedication, anyone can start a pharmaceutical company and potentially reap the rewards of being at the forefront of medical innovation.

Doing the necessary research is a vital step to starting your own pharmaceutical company. It is important to dive deep into the industry, research potential competitors, and understand the regulations that may affect the business. Research will help establish a strong foundation for a successful business model.

It’s important to understand the current market and how it is evolving. This should include a review of any new trends and technologies that can be used to differentiate the company from its competitors. The research should also include studying the current players in the market, their strengths and weaknesses, and how your company can compete effectively.

Regulations are an important factor to consider when starting a pharmaceutical company. Regulations vary by country, state, and province, so it is important to become familiar with the relevant local regulations. Depending on the scope of the business, some of the regulations may include workplace safety, environmental standards, labeling requirements, etc. It is important to consult legal experts to make sure you remain compliant with the applicable regulations.

Understanding Regulations

Operating a pharmaceutical business can be a daunting task as regulations are placed on the industry. It is important to understand all regulations that can potentially affect the business, such as those put forth by the FDA and other governing institutions. Additionally, having knowledge of the specific regulations in the state where the business is located is essential for success.

Navigating regulations can be a tricky process and may require assistance from an expert. The laws vary from state to state, making it difficult for business owners to be knowledgeable of the specifics. Consulting legal representatives or industry experts can be very beneficial when trying to stay in compliance.

Additionally, keeping up-to-date with any changes in the law is also important. This will help ensure that the business remains compliant and not subject to fines or penalties. Familiarizing oneself with industry standards and proper documentation procedures can go a long way into protecting the business from any potential legal complications.

Business Model for Pharmaceutical Companies

When it comes to running a successful pharmaceutical company, having the right business model in place is essential. There are several different types of business models available for companies in the pharmaceutical industry, and it can be difficult to determine which one is best for you. In this section, we’ll explore the different options and discuss some key considerations you should keep in mind when choosing your business model.

One of the most popular business models for pharmaceutical companies is the contract manufacturing model. This model involves outsourcing the production of your products to an experienced third-party contractor. In this arrangement, the product will be developed and manufactured according to your specifications, and you’ll only have to pay for the manufacturing services. This type of model is great for companies that are just starting out and don’t have the capacity to manage their own production capabilities.

Another option is the retail model, where you manufacturer and sell products directly to customers. This type of model works well for companies with a wide variety of products that require specialized marketing strategies and customer service. However, it requires a significant financial investment upfront and a lot of time commitment from management.

Finally, there’s the franchise model, where you partner with a larger pharmaceutical company to share resources and expertise. This type of model is great for companies that want to benefit from the resources of larger companies without having to build out their own operations.

No matter which business model you choose for your pharmaceutical company, it’s important to do your research and make sure it’s the right fit for your needs. Consider factors such as start-up costs, operational efficiency, and customer service when assessing different models. Additionally, it’s important to weigh the benefits and drawbacks of each model to ensure you’re making an informed decision.

Finance – Funding Requirements and Sources for Starting a Pharmaceutical Company

Starting a pharmaceutical company is no small task. In the modern age, it requires a significant investment of money and resources. Understanding the financial aspects of a pharmaceutical business is essential for success.

In order to launch a successful pharmaceutical business, a tremendous amount of capital will be required. This money will go towards all the necessary steps to get your business up and running, including: production equipment, research and development, marketing, employees, etc. The exact amount of money needed can vary greatly depending on the size and scope of your operations, but it’s safe to say that the cost of starting a business in this industry can be quite high.

When it comes to finding the money for your project, there are several options available. These include government grants, angel investors, venture capital firms, bank loans, and personal savings. Each of these sources carries its own advantages and disadvantages, so it’s important to do the research to find the best option for your specific needs.

Additionally, you should consider the tax implications of each funding source. Not only are specific laws and regulations in place for different types of funding, but there may also be certain deductions or credits available.

Finally, you should keep an eye out for potential incentives and subsidies from the government. Depending on where you are located, there may be programs available to help startup businesses in the pharmaceutical sector.

Funding a pharmaceutical business is a complex process, but it’s definitely achievable. With the right research and preparation, you can be sure to secure the capital you need for success.

Inventory and Supply Chain Considerations for Pharmaceutical Companies

When starting a pharmaceutical business, it’s critical to understand the inventory and supply chain considerations that go into making a successful venture. The necessary inventory components will vary on the size of the business, the scale of operations, and the products. It is important to understand the needs for purchasing, storage, shipping, and distribution.

For smaller businesses, it is important to purchase inventory in small amounts. This will help manage expenses and prevent product expiration. It also helps create flexibility if products or terms are updated frequently. For larger businesses, having sufficient inventory on hand is critical. An efficient supply chain is required to ensure product turnover happens regularly and in a timely manner.

Storage is another key consideration. Depending on the type of products being sold, different environmental conditions may be needed. Temperature control, special packaging, and other considerations must be taken into account. Products must also be protected from theft or damage. Knowing which facilities to use for storage, and the cost of transportation are also key considerations.

Shipping and distribution are two more important components. Clients need to receive the products as quickly as possible. To ensure this, it is essential to select the appropriate methods for transport and to manage the process appropriately. This includes selecting carriers, providing tracking information, and handling returns. Distribution involves getting the product to the end user in a timely, cost-effective manner.

Successfully managing the inventory and supply chain for a pharmaceutical business requires both knowledge and experience with the various processes and components. Having an understanding of these considerations is vital for running a successful venture.

Distribution: The Key to Reaching Customers

Getting products to customers is a critical factor in running a successful pharmaceutical business. Distributors are necessary for a company to reach their target markets effectively. Distribution networks can be complex and challenging to set up, but they are essential for a company’s success.

Once customers have been identified, a company must decide how products will reach them. Companies that distribute internationally require more complex systems than companies that stay local or regional. Different options include using a wholesaler or a third-party distributor, distributing directly to retailers or selling online. Each option has its own advantages and drawbacks, and should be carefully considered when developing a distribution plan.

When selecting distributors, it is important to look for ones with an established reputation, experience in similar products, and a good track record with other customers. Additionally, relevant certifications, such as Good Manufacturing Practices (GMP) certification, need to be taken into consideration. Once selected, distributors must be given the necessary information and resources to effectively market and sell the products.

Finally, setting up distribution channels is not a one-time process – regular evaluations and updates are necessary to ensure maximum customer reach and satisfaction. Distributors must be monitored, and customer feedback should be incorporated into the process. This feedback can help a company improve their product and service offerings to better serve their customers.

In the pharmaceutical industry, technology is vital. As the expectations around quality and delivery continue to increase, organizations need to be equipped with the right technologies and systems. Technology helps ensure that pharmaceutical companies are meeting all regulatory requirements, as well as providing products and services that are reliable and of a high standard.

When it comes to technology for pharmaceutical companies, there are several areas that need to be addressed. The first is automation. Automation can help streamline processes, improve production, and reduce errors. It can also help with inventory management, ensuring that products are quickly and accurately tracked.

Another area of technology is security. Pharmaceutical companies need to ensure that their data is securely stored and kept confidential. They must also have systems in place to detect any unauthorized access attempts. Companies should also investigate cyber insurance policies to provide additional protection.

Finally, pharmaceutical companies need to invest in customer interaction technologies. Having an online presence is essential to developing relationships with customers. This might include a website, social media pages, or even an app. All of these tools can help reach customers and build trust in the company.

By investing in the right technology, pharmaceutical companies can become more efficient and offer better customer service. Technology can also provide a competitive advantage over other companies in the market.

Operations for a Pharmaceutical Company

Operational processes are the backbone of any business, and this is especially true for a pharmaceutical company. Without efficient and effective operational processes in place, a company may struggle to survive. This section looks at what operational processes need to be considered when starting a pharmaceutical company.

The most basic operational processes involve setting up protocols for ordering and receiving inventory, controlling inventory, producing products, dealing with customer service issues, and managing finances. These processes must be able to respond to changing needs and be able to support long-term growth. An effective operational process also allows the company to remain competitive and profitable.

An important part of any operational process is quality assurance. Quality assurance involves procedures that are designed to ensure the safety and effectiveness of products. A company should have qualified personnel to inspect, test, and verify the quality of every product that is produced or sold. Quality assurance is absolutely essential for a successful pharmaceutical company.

Another key operational process for a pharmaceutical company is regulatory compliance. Regulations provide customers and other stakeholders with assurance that a company is adhering to accepted standards of practice and is providing safe products. In order to remain compliant, a company must always keep up with changes in regulations and make sure that their processes adhere to those regulations.

Having an effective and efficient operational process in place is essential for any business, especially a pharmaceutical company. With the right processes in place, a pharmaceutical company can remain competitive and profitable in the long run.

Prospecting Strategies for a Pharmaceutical Company

Marketing and promoting a pharmaceutical company can be quite complex due to the high level of regulations in the industry. Therefore, it is important to find marketing strategies that fit within the legal framework while still providing the visibility required to reach customers. Prospecting strategies for a pharmaceutical company can include techniques such as online advertising, networking, print advertising, direct mail and attending conferences.

For companies just starting out, online advertising is often an ideal option. There are several platforms available, including the increasingly popular social media marketing. This strategy allows companies to gain visibility without spending large amounts of money on advertising and can be tailored to reach a specific audience. It is also a good way to monitor website traffic and gauge customer interest in the products.

Networking is another powerful tool for a pharmaceutical company. Creating partnerships with other companies, medical professionals and research organizations can be beneficial in a number of ways. These partnerships can lead to new contacts, exchanging of knowledge and shared resources. It is also a great way to promote the brand and differentiate it from competitors.

Print advertising and direct mail campaigns can be useful to reach potential customers, although they can be expensive. These methods have the advantage of being able to target a specific demographic and reach people who may not be active online. Attending conferences is also a great way to create visibility and network with relevant individuals or organizations.

Insurance and Security

Starting a pharmaceutical business means taking measures to protect the company and its operations, and this includes insurance and security. It is important to ensure that your business is protected from any unexpected events and that you are able to meet requirements for the industry.

When it comes to insurance, the types and amount of coverage you need depend on a number of factors including the size of the company, the specific products you are manufacturing, and the type of distribution network used. For example, if you are selling products in both domestic and international markets you may need to have additional coverage. Additionally, you may need to acquire product liability insurance, property insurance, and more.

In terms of security, you need to protect your business from any potential theft or vandalism. You may want to consider investing in a surveillance system that monitors the premises in case of break-ins. You should also ensure that any confidential information is stored securely and encrypted to prevent any data breaches. You can also consider using biometric technology to further secure the premises and store confidential information.

By putting the right insurance and security measures in place, you can ensure that your business is protected from any potential harm. A well-thought-out security plan will help you protect your business from unforeseen risks and allow you to focus on running the best possible pharmaceutical company.

Starting a pharmaceutical company can be a daunting task, but with the right research, understanding of regulations, business model, financing, inventory strategy, distribution network, use of technology, operational processes, and marketing tactics, there is no reason why it cannot be successful. The key to success in this endeavor is careful planning and dedication. By following the steps detailed in this guide, you should be well-prepared to begin your journey to starting a successful pharmaceutical company.

Before jumping into anything too quickly, it is important to do your research and be sure that you understand all of the nuances and complexities involved. Companies operating in the pharmaceutical industry are heavily regulated, so it is critical to be aware of and comply with all laws and regulations. Additionally, establishing a strong business model and sound financials is of utmost importance when launching a new venture.

Having the right technology in place is essential to running a successful pharmaceutical business. By incorporating technologies such as artificial intelligence, robotics, and machine learning into operations, companies can become more efficient, reduce costs, and improve customer service. It is also important to remember that building a reliable distribution network and marketing strategy are integral parts of the success of any pharmaceutical business.

To ensure a safe and secure environment for your business, make sure to purchase the necessary insurance and adhere to appropriate security protocols. Finally, don’t forget to regularly monitor the progress of your business and adjust as necessary.

By following the steps outlined in this guide, you should have the knowledge and tools needed to create a successful pharmaceutical company.

Good luck and enjoy the journey!

FAQs about Starting a Pharmaceutical Company

1. what are the benefits of starting a pharmaceutical company.

Starting a pharmaceutical company can provide an opportunity to make a meaningful impact on healthcare and research, by providing innovative treatments and medications for medical conditions. It comes with many advantages such as revenue potential, global reach, and advancing the knowledge and effectiveness of medicines.

2. What research needs to be done when starting a pharmaceutical company?

When launching a pharmaceutical business, research should be conducted to gain a relevant and detailed understanding of the industry. This may include studying the science behind drugs, reviewing the market trends, analyzing competitors, and researching the regulations within the chosen countries or regions.

3. How do regulations affect a pharmaceutical business?

Regulations are an important consideration when setting up a pharmaceutical company – due to the safety and health effects of the products the company manufactures. Depending on the location and type of product, additional tests or licenses may be necessary to meet various regulatory requirements.

4. What types of business models are suitable for a pharmaceutical company?

There are several different business models that a pharmaceutical company may decide to pursue, including wholesalers, generic drug manufacturers, independent virtual companies, and branded drug companies. The choice of which model to pursue depends on the company’s goals, mission, and resources.

5. What does it take to finance a pharmaceutical company?

Starting a pharmaceutical business requires substantial capital investments for activities such as product development, approvals, production, marketing, and hiring employees. Depending on the size of the business, financing may be sourced from personal funds, venture capital investors, loans, or crowdfunding.

6. What inventory strategies should be considered for a pharmaceutical company?

The inventory management strategies for a pharmaceutical business should prioritize safety and efficiency. Companies should ensure they have the right medicines to meet customers’ needs, while avoiding overstocking and expiry. It’s also important to have a reliable and secure supply chain in place to reduce stockouts and waste.

7. What strategies are available to promote a pharmaceutical company?

Promoting a pharmaceutical business requires finding the right channels to reach the target customer base. Strategies may include in-person marketing, digital approaches such as website SEO, social media, email campaigns, and referral programs. Advertising and public relations may also be used to raise brand awareness.

Great, Thank you!

How to Start a Pharma Company in 10 Easy Steps

David Blok | Posted on September 19, 2023 | Updated on March 26, 2024

Introduction

Step 1: market research and pharmaceutical business ideas.

• Step 2: Creating a Business Plan

Step 3: Regulatory Compliance and Legalities

• Step 4: Team Building and Talent Acquisition
• Step 5: Location and Infrastructure

Step 6: Product Development

Step 7: clinical trials and approval process.

• Step 8: Manufacturing and Supply Chain Management

Step 9: Marketing and Sales

• Step 10: Scaling Your Business
• Frequently Asked Questions (FAQs)

Let’s face it: if you are reading this, you are one of two people: the entrepreneurial mind that dreams of building a business in an impactful industry, or you’re passionate about science and research and want to contribute to the better health of humanity.

Whether you envision yourself as a Pharma tycoon or simply long to casually drop ‘I make drugs for a living’ at dinner parties, the time has come for you to admit it – you want to build a Pharma company.

Why is a Pharmaceutical company a good investment?

Starting any company takes time, energy and money, but a Pharma business has even more to consider: it requires a combination of scientific expertise, business acumen, and regulatory knowledge. Whether you’re considering how to start a pharmaceutical business or exploring pharmaceutical business ideas you’re not just selling any products here, you’re impacting the health of people. I know what you are thinking: if it’s so difficult, why do people keep investing in Pharma?

Pharmaceutical manufacturing companies can be extremely profitable:

• These companies show resilience during market downturns, rising in R&D investments to stay competitive & flexible (Grand View Research Report, 2023).
• The industry has experienced significant growth during the past two decades, with Pharma revenues worldwide totaling 1.48 trillion dollars in 2022 (statista, 2024). Still don’t believe it? Check out this blog and discover India’s top Pharma Companies to find out h ow profitable pharma companies are in India.

Being such a lucrative market, it’s a natural good investment, especially if you have a good idea – which I’ll get to in the next chapter.

This brings us to our topic at hand, welcome to your comprehensive guide on how to make your venture a reality. In the upcoming sections, we’ll delve into the why’s and how’s of building a successful Pharma empire. Get ready for insights, anecdotes, and much more.

Let’s dive in!

The first step is always the hardest because there is nothing before it. On the flip side it’s a great opportunity to set the direction of your company. Your business is a blank canvas at this point, and you get to bring your vision to life, so the best way to set the wheel in motion is by understanding everything about the industry gap you are trying to fill, in practical terms, whether your idea is viable or not.

Before you dismiss market research as a formality, ask yourself: “Is there a chance my solution is old news compared to what’s already out there?”.

Unless you have the cure for cancer in your pocket, someone’s advancements in your field are worth taking a look at. At this stage, you should focus on two things:

• Understanding market trends and directions.
• Realizing if your big idea is profitable.

Market research will identify unmet needs within the healthcare system, such as patient preferences. By looking at emerging technologies, you can direct your research and development strategy.

Your company’s direction is in your hands at this point, and isn’t that exciting?

Where to start your research?

Start looking at insightful industry reports, academic journals, and the latest industry news, but remember to use credible and reputable sources.

The most important thing is to stay updated, especially on everything that concerns your big idea; market research will back it up. Staying on top of trends also ensures your product is aligned with market demand, and that you have a competitive edge, also called your unique selling proposition.

Step 2: Business Plan and Funding your Pharmaceutical Company

Once you’ve settled on an idea, it’s time to start shaping it into an actual enterprise. Welcome to a pivotal chapter: creating the blueprint of your operations, aka your business plan. Don’t have the faintest idea of what a business plan consists of? Pharmaoffer has got you covered.

Fundamentals of a bulletproof Business Plan:

• A market analysis – which you already did in Step 1.
• Outline of management and the company organization.
• All your products/services – which you probably already know.
• Customer segmentation.
• Marketing plan.

Pitch Perfect

Why is a detailed business plan crucial, you may ask? This plan isn’t just a formality; it’s your golden ticket. This single document is meant to convince stakeholders and investors that you’re not a risk; you’re a calculated and promising investment, which will increase trust and the chances of getting the funds you need.

So don’t be scared to dive deep into the big questions like who will benefit from your pharmaceutical innovations, and what makes it profitable. Paint the financial portrait of your venture with clarity—how will the funds be utilized, and what’s the return on investment? Venture capitalists, government grant applications, and loans are great routes to explore. Your business plan will prepare you to pitch your idea to the right people.

Okay, this is where it gets tricky, but it’s why pharmaceutical business entrepreneurship isn’t for everybody. You are too far along in this journey to stop now, so it’s better to keep going.

Regulating to triumph

We know that acronyms like FDA, GMP, and CEP may be scary, but like we said from the start of this journey: when it comes to the health of the population, you can’t risk it. Regulations ensure your company is ethical and safe. Dismissing them puts your entire operation at risk of getting a bad reputation, not to mention facing penalties later on. Oh, and besides, no funding without compliance is just not going to happen!

What is your business structure?

Now, let’s talk about how to set up and open a Pharma business. Should you go for an LLC (more partnership-oriented) or a corporation, and why does it matter?

The selection of a business structure is a crucial decision for a company because it impacts various aspects, including:

• Legal responsibilities.
• Liability protection.
• Ability to raise capital – we know this sounds like a broken record on this one, but money it doesn’t grow on trees, right?

Remember, it’s not just about paperwork; your business structure shapes the core of your company. Speaking of structure and shape, it’s time to shape your physical company.

Step 4: Building your A-team

You’re the mastermind behind this venture, but you don’t have to do everything yourself. Like a formula, it takes plenty of ingredients to make one solution. In this section, you’ll select the best people to represent and help grow your business.

The trick to knowing whom to hire is simple: point out the necessary fields for your business to run that you need to hire for, and find people who can excel at them. Think R&D, supply chain management, sales, and, of course, medical professionals. ´

Extra tip: remember that sometimes you don’t want to hire the best technical person, but someone who can complement your team’s attributes, like, for example, someone with a proven track record of adaptability and communication.

Step 5: Location, Location, Location

The perfect location is a no-brainer: it is the one closest to your potential partners. Places like research centers for experiments, hospitals for data, or universities for talent scouting are where you wanna be. Just think of how your idea can improve with these extra resources.

A place to call…office

Ideally, if you picture a creative and productive atmosphere, it won’t be a cramped space, poorly lit with bad chairs, that won’t cut it. Your facilities are the day-to-day of your operation, where some say, the real magic happens, so make sure your spaces are up-to code and optimized for the tasks at hand. Remember, a positive environment boosts morale and increases efficiency.

Admit it, you’ve been thinking of this since the very beginning of this adventure. After all, this is what you came here for. Whether it’s a new drug or medical device, the development phase is the fun, and most important part. Let your R&D work shine to bring your vision to life.

Trials and tribulations

Having a finished product means one thing, and one thing only in the Pharma world: clinical trials. Clinical trials aim to provide a scientific basis for advising and treating patients.

But don’t be discouraged if it doesn’t work out. Even when researchers don’t obtain the outcomes they predicted, the trials results can help point scientists in the correct direction of their research. Trials present their challenges, but as cliché as it is, every challenge is an opportunity in disguise and a testament to your team’s innovation capacities.

Think you heard enough about clinical trials? These are the final stages before your product enters the market, and needless to say, it won’t enter without the green light. How do you make sure it’s approved then?

• Rigorous protocol adherence.
• Collaboration with regulatory bodies.
• Scientifically proven efficacy and safety.
• Real-world testing for validation.

Extra tip: real-world testing is a good option to further validate and solidify product claims that may give you an interesting competitive edge.

Passing this frantic stage is a monumental milestone, and it’s one foot in the door of your Pharmaceutical business success. If you are in this stage, or just looking to dive deeper into the complexities of API’s clinical trials, check out our blog, API Clinical Trials: From Preclinical Trials to Post-Marketing Surveillance.

Step 8: Pharmaceutical Manufacturing and Supply Chain Management

Quality control isn’t just between your lab and office walls most of the time unless you manufacture everything in-house, but is that cost-effective?

We are not going to go into this question but leave it for a promising blog about the pros and cons of API in-house manufacturing or out-sourcing. This time we’re going to talk about the Pharmaceutical company’s supply chain.

As you need to make sure every substance you use is under the same quality control as your business, how can you be positive you are purchasing APIs from a qualified supplier?

We’re not gonna lie, unfortunately this step can be a dead end as many API manufactures aren’t registered in a public contact base.

You really need to know the business and ask around, a total nightmare. This is our mission statement: at Pharmaoffer we want to match the best certified API manufacturers with businesses like yours, so to provide resources for both and enrich Pharmaceutical business supply chain with qualified options.

Your supply ally

When choosing the right suppliers, the biggest worry is compliance standards, so make sure your supplier:

• Meets all compliance standards.
• Is up to speed with industry best practices.
• Has the means to make deliveries on schedule.

You have a finished product, your team is working and the place up and running, so it’s time to find some clients. We do this with a marketing and sales strategy.

What do people think of when they hear your company’s name? Do you have a logo? These are some of the questions you need to clear with the proper professionals.

Branding is understandably the last thing on your mind, but don’t make the mistake to overlook it indefinitely. Nowadays, if your business doesn’t look good it won’t be credible. Branding is how you present your company to the world. It’s your mission statement, your corporate culture, and your values. It will help you find your market and secure a strong position in it.

Getting the word out

Marketing is about business survival, there is no denying it. In this increasingly visual world it’s not enough to have a great product, you need to present it well to elevate it. The way you do so is with marketing tools.

Now don’t fall into cheap marketing tactics: in Pharma you can’t make any false claims, exaggerate benefits, or show dubious testimonials. This will kill your entire operation. Marketing in the Pharma sector demands a careful balance of awareness-raising and ethical considerations. Credibility is central, so keep it real, and let your amazing product and integrity attract customers.

Because we understand how complex marketing strategies can be, at Pharmaoffer we wrote you a startup guide to navigate online marketing in the pharmaceutical sector called Online marketing in pharma; where to start?   Feel free to take a look.

Step 10: Scaling Your Pharmaceutical Business

You finally have a Pharma company, congratulations and we take no credit for it. Now that you have a growing business, the question is: How big do you wanna get? We’ve seen how much does it cost to start a pharmaceutical company and remember that scaling and it isn’t just about growth, it’s about smart growth. Scaling is about expanding your operation, and it should be a calculated decision.

To make the right move you need to be on top of market demand, KPIs tracking, and consult your team to know when it’s the right time to do it.Bigger the business, bigger the challenge.

Bigger the business, bigger the challenge

A bigger business is a complex one. From staffing to resource allocation, be prepared to adapt your business strategies as you expand.

Extra tip: keep your staff informed and let them be a part of the change. It will make them more involved in your business success.

You made it to the end yay!

We saw how to start a Pharmaceutical company investment which is no small endeavor, but it’s a rewarding one for sure! You are building something of your own, following your heart and creative dreams and the best of all, you’re saving lives while you do it, how great is that?

Okay, it’s time to get to work, so roll up those sleeves, and get started if you haven’t already. We have no doubts that if you pay attention to these 10 steps, you have what it takes to build your successful Pharmaceutical company.

Needing further assistance to find the right API suppliers for your business? Fill in the form to contact Pharmao ff er and schedule a free meeting to take your business to the next level.

Is it hard to start a pharmaceutical company?

Yes, but it's also rewarding. Be prepared for regulatory hurdles and significant initial investment.

How long does it take to launch pharma company?

On average, it could take 1–3 years, depending on the business model, licensing, and other factors.

Can I start a pharma company without a medical background?

Yes, although you'll need a team of experts in medical and scientific fields. Your role may be more focused on business strategy and growth.

What are the biggest challenges in starting a pharma company?

Regulatory compliance, securing funding, and market competition are some of the biggest hurdles you'll face.

• APIs & Manufacturing (15)
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• Industry Insights & Trends (11)
• Interviews & Case Studies (9)
• Market Analysis & Data (14)
• Medicines & Access (17)
• Regulations & Standards (19)
• Sales & Marketing (15)

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Pharmaoffer is a B2B platform where you can find all qualified API suppliers in one place

• Business Plans Handbook
• Business Plans - Volume 03
• Pharmaceutical Company Business Plan

Pharmaceutical Company

BUSINESS PLAN

PAIN AWAY LTD.

1117 High St. Poughkeepsie, NY 13495

The company described in this plan has moved beyond the initial start-up phase and is now seeking investors to finance its growth. Much of the plan, therefore, is geared toward persuading, explaining, and reassuring potential investors that the company (which produces a therapeutic, topical pain cream), is well-managed and stable. The in-depth analysis of the company's competitors is an outstanding feature of this plan, as is its market research.

EXECUTIVE SUMMARY/OVERVIEW

Competition.

• PROPERTY & FACILITIES
• PATENTS & TRADEMARKS
• RESEARCH & DEVELOPMENT

GOVERNMENT REGULATIONS

Insurance and taxes, corporate structure, risk factors.

• RETURN ON INVESTMENT AND EXIT
• ANALYSIS OF OPERATIONS & PROJECTIONS

FINANCIAL STATEMENTS

Type of business.

Non-prescription drug wholesalers; US SIC Code - 2834 Pharmaceutical Preparations.

Company Summary

Pain Away Ltd. is a going concern, a Delaware corporation formed in January 1995 to manufacture and sell its premier launch product Pain Away, a topical pain remedy using FDA-approved homeopathic ingredients developed for the simple purpose of relieving pain. The company was formed by its parent S-corporation, Peale, Inc. in order to market products nationally and internationally. Peale, Inc. was formed in February 1994 to complete the development of the launch product. The formation of the company was a significant step in a 9-year process of refining and testing a homeopathic formula first used by company founder and CEO Robert Peale to alleviate his pain from carpal tunnel syndrome. The R&D phase of this product began when Mr. Peale purchased the original formula, did a thorough study of homeopathy, and refined the formula to its present marketable state. From the beginning of R&D, Mr. Peale worked within FDA guidelines in order to secure FDA registration. Then, in February 1994, the company was formed to finally manufacture and sell the product. Starting with only a handful of customers, including some professionals, chiropractors, physical therapists, etc., only 19 months of operation have yielded 12,000 individual customers with an 80% reorder rate. The current customer base now includes medical doctors from different specialties, sports trainers, and athletes, both professional and amateur. The company expects to show a profit in 1996 and estimates that it will be very profitable in 3 years.

Mr. Peale is 49 years old and has a 25-year history in sales, sales management, and marketing for a tool distribution company. His deep study of homeopathic medicines started in 1985 and included studies in nutritional supplements. Mr. Peale has been invited to sit on a newly-formed FDA committee addressing the growing national interest in natural medicines.

Curtis Company president, Ms. Alana has 25 years of experience in retail and direct sales. She has been a senior sales director and sales trainer for Beautiful You Cosmetics, has owned and operated a retail sporting goods store, and has managed a 15 person, $1 million department for a major chain retailer. She also has some banking experience.

Vice-president of marketing, Ryan Lemon has 32 years of experience as production manager, buyer, sales manager, and marketing manager. He was director of marketing for Pilgrim Health and was responsible for their first launch into New Jersey which led to their first $18MM in sales (in 3 years). He has a BS degree in textile engineering and has also done independent marketing consulting.

Product and Competition

The R&D mission was to develop a greaseless, odorless, topical cream which was measurably more effective at relieving pain than any other OTC (over the counter) topical product. This mission has been accomplished. The company has collected anecdotal, testimonial, and uncontrolled medical study evidence that Pain Away is more effective than the leading topical analgesics such as Arthritin and others. The product's effectiveness in relieving pain is its most powerful benefit, besides the added benefits of it being greaseless and odorless. What distinguishes Pain Away from any other topical analgesic in this still-growing $402.1MM market is its advanced homeopathic formula - a refined blend of 11 FDA approved pure and natural ingredients. The typical OTC topical analgesic works to either block the sensation of pain or distract perception of deep pain by "counterirritating" another localized area near the pain. Pain Away's formula is different. Pain Away treats pain at its source. It stimulates improved circulation in the micro-capillary system in the ligaments and tendons, where most pain is felt. Pain-relief from Pain Away is the result of the body's own self-healing. It also can be applied several times a day because it is odorless and greaseless. The US pain management market ($15.2 billion by 1997) is a mature market with intense, established competition ("The Market for Pain Management Products in the US - Introduction, Drugs, Devices, Trends, and Market Structure," in FIND-SVP). With future pharmaceutical market growth dependent upon new and innovative product additions, Pain Away is entering the field at the right time. The company will distinguish itself and its market position by dedication to the development of only natural-ingredient products. Since its unique formula of ingredients already has FDA approval, the company aims to penetrate the OTC pharmaceutical market, where new products traditionally find success. Here Pain Away will compete with topical as well as internal analgesics, including aspirin, acetaminophin and ibuprofen. An estimated 4,000 people a year die from aspirin overdose. A condition known as "analgesic neuropathy" can result from extended or inappropriate use of analgesics. Medical studies linking heavy usage to health problems have affected aspirin, acetaminophin, and ibuprofen. Pain Away can be marketed as a substitute for (reducing overdose risk with internal analgesics), or as a supplement to (using Pain Away can reduce needed dosage of internal analgesics) internal analgesics when used for certain pain relief. Furthermore, Pain Away is not contraindicated for use with any other medication. This broad-based appeal is built upon the reliability of Pain Away's effectiveness in relieving pain, inflammation, and spasm associated with arthritis, bursitis, sciatic spasm, neck/back pain, tendonitis, tennis elbow, tension headache, achilles tendonitis, and carpal tunnel syndrome.

A second product, a natural anti-inflammatory nutritional support system formula known as "Pain Away Plus," will soon be marketed as a companion product to Pain Away. This multistaged formula is a combination of trace minerals, herbs, and a natural cartilage-derived substance. The company has long-term plans to develop more health-related products.

Funds Requested

Company principals have invested all available personal assets into the product development and operations to date. The need for capital is in the context of the readiness of the product for mass marketing. Management is seeking a $1,500,000 equity investment in exchange for a suggested 30% ownership of the company. All terms of financing are negotiable in order to meet the financial requirements of the investor.

Use of Proceeds

Advertising & promotion campaign - $1,200,000 (see below); Market research - $300,000. The company anticipates the need for follow-on financing after 24 months of business.

Financial History

Sales were first made in 5/94 under Peale Inc. ($143,881). As sales expanded nationally, Pain Away Ltd was formed in January 1995. All sales since then have been under Pain Away Ltd.

Financial Projections

With capital request accomodated, the company believes that Pain Away will jump in sales starting in 1996.

The company will attempt a public offering based on year 2000 earnings. If there is no public market and no prospect for a public market in the near future, then the company will offer to buy back the stock owned by the venture capitalist. A predetermined price could be set ahead of time, if desired by the venture capitalist.

The product effectiveness, evidenced largely through anecdotal evidence, personal testimonials, and repeat sales, has formed the basis for the future growth of the company. Together with a second, complementary product (nearly ready for market), the launch product will be aggressively mass marketed as a pain management system for the next five to ten years. Past and current sales have been to end-users, health professionals, and to some retail chains. The company and product are now poised for first stage expansion. Over 30 target wholesale markets have been identified. While the company uses its marketing strategy to enter these wholesale markets, simultaneous efforts will be made to develop research protocols. Management is confident that the anecdotal evidence and personal testimonials will be strengthened by controlled studies, designed to test the effectiveness of the product and demonstrate the physiological healing activity stimulated by the formula. With scientific credibility, the product will not only build its position in the $150 million homeopathic product category but will also strengthen its transition into the formidable mainstream topical analgesic category.

Future research is planned, based upon inquiry, in order to adapt the formula for animal use (Pain Away currently being tested on thoroughbred horses).

At the end of five years, the company intends to have at least one additional health product and should be able to go public off its revenues. The long-term goal for the company is to become an entrepreneurial leader in the development of natural products for various segments of the health care market. The company plans to capture enough share of the topical analgesic market to become either a viable joint venture partner or an acquisition candidate.

The product formula and delivery system are proprietary. The formula is uniquely advanced and is nearly immediately effective in relieving pain. Homeopathy and immunization have much in common, namely the principle of similars, which states that whatever a substance causes in a large dose, it can stimulate an immune response to defend against it in a small dose. It works by the principles of stimulation to the body's own self-healing mechanism and by the scientific balancing of its natural active ingredients through a dilution process called micro-dosing. Micro-dosing has given homeopathy its 200-year history of safety with no known side effects or toxicity. This self-healing process is in contrast to the majority of commercially successful topical analgesics, which contain counter-irritants, including the newer capsaicin-based products. These ingredients cause a superficial inflammation on the skin which masks pain by deadening the sensation of pain in the epidermal nerve endings only, or by distracting from the perception of pain by irritating an area near the pain source. The Pain Away formula has been developed with precision and balance and is a product that is effective and safe for use on all skin types. Pain Away's eleven active ingredients stimulate improved circulation in the micro-capillary system to ligaments and tendons, where most pain is felt. Pain relief is the result of the body's self-healing.

The manufacturing is sub-contracted out to a highly respected FDA-licensed manufacturer of homeopathic products.

An important unique feature of Pain Away which distinguishes it from other homeopathic remedies is that Pain Away is a topical treatment and is not a systemic treatment. As such, it requires little knowledge to use and is conducive to cross-merchandising in the mainstream analgesic category. Furthermore, since Pain Away is a formula of ingredients, it provides a broad spectrum of effects as compared to single remedies.

The personal commitment of the founder to relieve his own pain also adds a unique value to the story of this product - a story which can enhance marketability - to anyone who is in pain or anyone who knows someone in pain.

Although Pain Away is an homeopathic product, the company will position itself as a natural ingredients company - not necessarily homeopathic. All the company principals plan to engage both septics and advocates of complementary medicine by applying rigorous scientific standards equally across the board, for both conventional and unconventional treatments. Contacts have already been made with the National Institute of Health regarding future research.

Product Description

The product is a specialty consumer good carrying a suggested retail price of $19.95 for a 3.7 oz. jar (1.9 oz. jar also available at $12.95). The jar is designed with a medical appearance. The jar is easy to ship in multiples, is easy to stack on a shelf, is aesthetically pleasing, and has an easy-to-handle screw cap. The actual cream is greaseless, easy and pleasant to apply, and is odorless. Pain Away has, to date, largely been sold directly to end-users, and wholesale to retailers, distributors, and catalogues. The markets have supported the suggested retail price, which was arrived at by surveying market research supporting the $19.95 price along with the perceived value of the product compared to similar products at about the same price. This price also yielded a gross profit of $3.75 per jar and allowed for 100% markup from wholesale.

The eleven ingredients are readily available through top-quality labs which control for purity and authenticity. The cream is compatible with any medication being taken. The product carries a money-back 30-day guarantee.

Purchasers of the Product

Preliminary studies done by independent treatment professionals (no control group used) have shown that Pain Away has been effective for relieving the pain, inflammation, and spasm associated with arthritis, bursitis, sciatic spasm, neck and back pain, tendonitis, tennis elbow, tension headache, achilles tendonitis, and carpal tunnel syndrome. Anyone suffering these ailments, treating these ailments, or caring about anyone suffering these ailments is a potential purchaser of the product. A New Jersey hockey team uses Pain Away prior to workouts, competition, and for pain relief. The head trainer for the team says, "There's no product better for contusion of the quadriceps." He has reported shorter recovery times as a result of using Pain Away. Reports from athletes are that using Pain Away before and after workouts yields less cramping, fatigue, and soreness.

Top purchasers of TPR to date:

The total market for OTC internal and topical analgesics is estimated at $3.6 billion for 1995 and is projected to be $4 billion by 1997. With over 400 brands saturating this mature market, growth is still occurring through new products and product innovations. Driving this growth are:

• increasing use of pain management products for the over-50 population segment, whose numbers are increasing
• increasing awareness that pain does not have to be tolerated and can be treated
• price increases

Body/Muscle Pain Market

The market is dominated by internal analgesics:

Pain Away is a new product to this sizable OTC pain-relief market. It will enter this large arena riding on its effectiveness and coming from the new and growing alternative health care market segment. As a new OTC product, Pain Away has such a broad-based appeal that it will be sold to a large portion of the total OTC pain-relief market (both internal & topical), estimated to be 84% of all US adults and growing as the baby boom population ages and concerns regarding age-related ailments, such as arthritis, increase. Of this 84%, about 25% alone use pain-relief products for body/muscle pain for which Pain Away is especially suited. Just this one type of ailment offers a substantial market potential:

If only 40.3 million Americans (25% of 84% of adults) use an OTC pain-relief product three times a week for body/muscle pain alone, then the market potential is 6.3 billion uses of a pain-relieving product per year. Past use of Pain Away has indicated that a minimum of 3 applications per week would use about one 3.7 oz. jar per month. A conservative yearly estimate would be 10 jars per year, with consistent use. In order to reach a five-year sales goal of $50 million (6.7 MM jars), 667 MM consistent purchasers (10 jars/yr.) are needed. Product history has indicated a consistent 80% reorder rate, so at this rate, 833,000 original purchasers are required. This figure is 2.07% of just this one market segment. The company is very confident that it can capture 2.07% of this market segment within five years, especially considering that the roughly 40 million Americans who exercise on a regular basis, and who are aging, are included in this segment. Anecdotal reports from athletes who use Pain Away are that it can prevent injuries by "warming up" vulnerable muscles and joints prior to a workout. The product has wide applicability within this segment. The table below shows the percentage of the body/muscle pain market segment required to meet the next 5 years of sales projections.

These numbers are based upon a wholesale price of $7.50 per jar and a usage rate of 10 jars/year with a segment population of 40.3 million potential purchasers.

The prescription pain relief market is a distinct market which Pain Away will not attempt to penetrate. Pain Away can, however, compete directly with nearly all pain-relief products because of its unique identity of being both a substitute and a supplement to ail competing products. This uniqueness fits a projected market shift from internal to topical analgesic use as the population ages, and derives from 2 factors: 1) Use of Pain Away can reduce the needed dosage of any pain-relieving medication and 2) Pain Away is already part of a rapidly growing segment (25%-30%/year) of consumers who use alternative health care because of a disenchantment with OTC drugs and a concern about side effects with adverse reactions. Use of Pain Away can reduce needed dosage of other pain-relieving medications. As stated earlier, Pain Away's effectiveness is based upon the homeopathic principle of microdosing. While it promotes self-healing by stimulating blood flow to micro-capillaries, it remains safe for all skin types and with use of any other medication. Anecdotal evidence (from hospitals, some doctors, and occupational rehab center) has indicated that use of Pain Away alone has yielded positive results and use of Pain Away, along with other treatments, has seemed to accelerate recovery. As always, this kind of evidence will be scientifically studied. The salient point is that Pain Away can be a substitute and/or a supplement in pain management, and thereby reduce needed dosages of other medications.

Alternative Health Care Segment

Homeopathy, being an established (officially recognized by UK National Health Service) and significant alternative mode of treatment, is gaining increasing acceptance in mainstream American health care. The National Institute of Health has even awarded grant money for research in alternative treatments, including homeopathy. Drug retailers report that homeopathy may be the fastest-growing category in the trade class of drug chains. Since homeopathy is gaining acceptance as an alternative treatment, the market segments which are already embracing these alternatives will continue to be targeted in the company's initial expansion. These segments include people ages 25-elderly, who seek improved quality in life, and whose lifestyle values involve "newness." This segment includes most of the "baby-boomer" population, estimated at over 75 million. The market of alternative health care seekers is characterized by patients who can and will pay for their own care. As much as 70% of alternative medical treatments are still paid for by patients themselves rather than insurers. This kind of purchasing indicates a willingness to try an alternative product and continue purchasing based upon perceived value of the product's effectiveness. Company management has been encouraged by the consistent 80% reorder rate and knows sales will be sustained once initial purchases are made. The alternative health care market is of respectable proportion. According to the New England Journal of Medicine (1/28/93), 34% of Americans spend $13 billion/year on alternative treatments such as chiropractic, acupuncture, massage, and homeopathy. Pain Away is already marketed to all of these treatment specialties so it will reach the spectrum of alternative treatment. This 34% of Americans are familiar with the term "homeopathic," so there's a consumer predisposition to being further educated about homeopathy as a value-added natural ingredient alternative.

The company will build an early market position on the alternative health-care market and will join the growth of the homeopathic segment as it moves from the fringes to the mainstream of the OTC pharmaceutical market.

Alternative Market Potential:

If only about one third of Americans use an an alternative pain-reliever just twice per month, then the market potential is 2 trillion uses of an alternative pain-relieving product per year. Market indicators are that both the number of users and the frequency of use will increase as the population ages. The use rate of 2 times per month converts to 2 jars of Pain Away per year with consistent use. Again, in order to reach the 6.7 million jar sales goal ($50 MM), at the re-order rate of 80%, Pain Away would have to make 4.2 million initial sales in order to sustain 3.3 million consistent purchasers. This size customer base comprises 4.71% of the growing alternative health care market. The company believes that this sales goal is attainable within the next five years. The table below shows the percentage of the alternative health care market segment required to meet projected sales.

These numbers are based upon a wholesale price of $7.50 per jar and a usage rate of 2 jars/year with a segment population of 89.1 million potential purchasers.

Narrowing the Market Focus 2X

The market potential for pain relief products is huge. By narrowing the focus to product category sales, the potential becomes more exact. Pain Away's product category is within the topical analgesic market, estimated at $402.1 MM annually with a projected $522.7 MM market in 1996 (30% growth) and $692.6 in 1997 (32.5% growth). Starting with $522.7 as the base market volume, and with 30% growth per year for the next 5 years, Pain Away would have to capture 3.33% of the year 2000 market volume to make its sales goal of $50MM. Management believes that these goals are attainable.

The table below shows what percentage of the topical analgesic market will meet Pain Away's sales projections.

The focus can be narrowed further to the homeopathic product category, which is growing at a rapid rate at this time. The dollar volume of this segment is estimated at present to be between $150 million and $215 million and expected to grow at a rate of 25% to 30% a year. Some market-trackers say that retail sales haven't grown enough to support the existing number of homeopathic manufacturers and that a shakeout will consolidate sales in the hands of fewer manufacturers. The forseeable trend, however, is progressive growth from the fringes to mainstream markets, and at a rapid rate. The table below again shows percentages of this dollar volume required to meet sales projections.

These numbers are based upon a 1996 volume mid-point between the projected volume range of $150 MM and $215 MM. Growth rate is 25% a year. At first glance these percentages may seem daunting. However, the manufacturers supplying this niche are relatively few in number and therefore hold significant market shares A new player can get a reasonable market share with the right product and marketing plan. The mainstream merchandising of homeopathic products started in the early '90's and has been tested as a lucrative direction. Company management is very confident that Pain Away will gain enough share points to capitalize on the rapid growth of this product category. Pain Away will not remain in the homeopathic niche. Its effectiveness will make it competitive with mainstream topical angalgesics.

International Markets

The company will also develop an international market. A 10,000-unit order has already been received from a distribution company in Hungary and is awaiting final approval from the Hungarian State Department of Pharmacy. A small order was also sent to well-known sports figure in Spain. Discussions are underway for this individual to start large-scale distribution. The homeopathy market in the UK is estimated at 18M pounds and in Germany at 120M pounds, so European marketing could be strengthened by the homeopathic identity alone. In Germany, an independent division of the German Federal Health Agency publishes monographs on the safety and efficacy of herbal medicines. The company believes that Pain Away would fare excellently under such review and will carefully research and plan when and how to reach such markets.

There are many companies competing for shares of the 3.6 billion dollar OTC analgesic market. The major players are the internal analgesic manufacturers:

The balance of the OTC internal analgesic market is held by private label companies and "others." The major strengths of this level of competition are obvious in comparison to Pain Away's present market position. The major players have:

• a manufacturing cost advantage,
• sophisticated market knowledge and access,
• established sales capability,
• strong R&D capacity,
• and of course, brand name loyalty.

An important competitive strength of Pain Away is that it is topical - pain relief is accomplished without risk of overdose and consequent risk of serious side effects. This competitive strength derives from a previously noted shift in the market from internal to topical analgesic use. This shift in consumer preference, along with Pain Away's effectiveness, can position the product as a substitute/supplement among these large competitors. Management is ever mindful that mainstream pharmaceutical companies are watchful of the homeopathic market and will act accordingly should market share be lost to homeopathic remedies. Becoming a viable acquisition candidate to any one of its major competitors is a realistic goal. Pain Away management is committed to quality product development and is also open to strategic alliances which would enhance its market capability.

The competition in the topical analgesic market is head-to-head. The top competitors are:

The basis for the competitive analysis is Pain Away's most competitive feature:

• It doesn't have any of the aforementioned advantages held by the major, well-known players in this market - yet.
• It doesn't have widespread brand name recognition - yet.
• It doesn't have appreciable market share in topical analgesics, alternative health, or homeopathy - yet.
• It does have a unique formula of safe and effective ingredients which none of the above products have.

All topical analgesics contain counter-irritants, including camphor, menthol, methyl salicylate, eucalyptus, wintergreen, and even the popular capsaicin. These ingredients, even when blended, act primarily to cause a superficial inflammation on the skin. This inflammation serves to hide the pain by deadening pain receptors in the skin.

What distinguishes Pain Away from all of the above products is that the eleven active homeopathic ingredients stimulate the blood flow in the body's micro-capillaries and act synergistically with the body tissue. This stimulates the body's own self-healing. Pain is treated at its source. Company management believes that the unique effectiveness of Pain Away will give it competitive clout. The issue then becomes how to compete.

Although Pepperub (Pepper) and Vapol (Athens) enjoy the largest market share, they are vulnerable to new product introductions. Menthol Plus (Lucia) held the top position in this category last year until Pepperub was re-packaged and relaunched with line extensions. That relaunch along with a relaunch of Zanprin boosted sales of both brands and put Pepperub back on top. Pepperub, Vapol, and Mentholplus are all menthol-based products. Zanprin is a capsaicin-based product and has boosted usage of its relatively new ingredient. Other relatively new capsaicin products are Capcreme (Bioderm) and Capthol (Men-Thol Co.).

Company management believes that Pain Away is generally more effective than Pepperub and Vapol. However, these venerated brand names, large advertising budgets, and consumer loyalty are formidable competitive advantages. Pain Away will focus on other competitors in order to gain a market position.

The key competitors are Menthol Plus, made by Lucia and Zanprin, made by Skin Care Corp.. Menthol Plus is a menthol-based product which Pain Away has encountered head to head in the sports market. Menthol Plus has a retail price advantage in the mass market, selling for $4 for a 2 oz. tube. This price difference is of little concern because Pain Away will promote itself as a high value product. The topical analgesic, alternative health, and homeopathic markets all support pricing based on perceived product value. Menthol Plus' manufacturer has reduced the advertising budget for this product (about $2 million) recognizing from a 21% decrease in 1994 sales that the product has matured. The company plans to acquire other brands (no topical analgesics) and extend its other lines in order to generate sales growth. The company sells another topical analgesic which is doing well in sales but has not reached the same position as Menthol Plus. Pain Away will monitor the life cycle of Menthol Plus and move to gain any market share it might lose.

Zanprin, made by Skin Care Corp., is gaining market share because Zanprin (.025%) and Zanprin- X (.075%) are capsaicin-based products. Capsaicin, derived from cayenne peppers, has created a new segment in the market and is very popular. Other companies are making capsaic in products but Skin Care Corp. attracted market attention by relaunching Zanprin as an OTC consumer product. It had been marketed for seven years to physicians and kept behind the counter, carrying the credibility of a prescription product. In early 1995, the product was re-packaged for shelf space and supported by TV ads. Despite commanding premium prices ($19.95/2oz of Zanprin-X), the product has done dramatically well.

Skin Care Corp. claims that Zanprin is the "only brand with physician endorsement and specific clinical support." This is a credible claim, cultivated for seven years, and obviously contributing to sales of the product.

Skin Care claims to be the first in the industry to develop their highly purified version of capsaicin for a pharmaceutical base. Zanprin distinguishes itself by promoting controlled clinical studies which have supported its effectiveness. Skin Care claims that such clinical trials don't apply to other, less pure, capsaicin formulas. This scientific feature enhances product credibility among physicians and pharmacists.

The management of Pain Away Ltd. recognizes the effective marketing strategy used by Skin Care because it is similar to their own strategy. Advertising and promotion expense is critical. With proper capitalization, Pain Away can compete because the Pain Away homeopathic formula is unique and effective. Many capsaicin users, including Zanprin users, have complained about the burning sensation caused by capsaicin. Pain Away will stand up to any topical analgesic on the market and do very well with comfort, safety, and effectiveness. The company needs to get this message out. The seven-year product life of Zanprin, supported by unique and heavy TV advertising, gives Zanprin quite an edge. Zanprin is now a "new" growth product and Pain Away can grow behind it, by comparing ingredients and effectiveness at every turn. Pain Away is also in the same price range as Zanprin, doing slightly better with $19.95 for a 3.7 oz. jar or $12.95 for a 1.9 oz. jar.

Zanprin is not the "only brand with physician endorsement and specific clinical support." Pain Away has been cultivating health professional support since the R&D phase. The product is heavily endorsed, and more medical support is developing. Many of Pain Away's sales to date have been to health professionals. Regarding clinical support, Skin Care's success with this strategy underscores the strategic importance of Pain Away's plans for controlled clinical studies.

Speaking of "highly purified" formulas, Pain Away can compete strongly with any formula on the market, especially capsaicin-based. The company wants to discuss purity of ingredients and formula and will do so in all promotional efforts.

The remainder of the products listed in the top competitor list have of course the same advantages that any established company with significant market share has. Beyond these immediate competitive advantages, Pain Away can compete, again, on the ingredient effectiveness basis.

Aspratin, an odorless rub which contains Salycin, sold well when it was introduced in 1992. It held third place among topical analgesics at the end of 1993. It has since been surpassed by capsaicin-based Zanprin. Bioderm developed Capcreme and lowered its price when Zanprin was relaunched.

Capthol was recently developed by the long-established Men-Thol Co. and is a capsaicin-menthol blend designed to compensate for the sometimes delayed pain relief when using capsaicin alone.

Salicreme is a methylsalicylate product which has shown flat growth and has lost market share.

Lyptum was a rapid-growth product in 1990-1991 but has since lost market share. Besides the well-established brands like Pepperub, the products which are gaining in this market are the capsaicin-based. This product category is known to be affected by product innovation and development. With proper support, Pain Away will take a respectable market share.

Homeopathic Competition

The competition takes place in the drug chain arena. Homeopathy may well be the fastest-growing category in the trade class of drug chains (20% of all homeopathic product sales). Among the growing number of drug chains which are giving shelf space to homeopathic products are: Walgreens, Medicine Shoppes International, Thrifty Payless, Eckerd Corp., Edgehill Drugs, Genovese and FEDCO, a California supermarket chain. Research published in the Journal of Clinical Pharmacy and Therapeutics states that 27% of US pharmacists consider homeopathic medicines helpful while only 18% consider them useless. The crossover of homeopathy from health food stores, where sales are still strong, to mass markets is gaining momentum.

As mentioned earlier, there are relatively few companies supplying homeopathic products to the mass market. There are five major producers/distributors of homeopathic products.

Health System, Homeopathic Co., and Life-Right pioneered the distribution of homeopathic products to chain drug stores in the early 1990's and are now market leaders, although more companies are entering this lucrative market. Health System Products now has about 40% market share. Homeopathic Co. and Del Sol are aggressively developing the crossover into mass marketing with line development and heavy TV advertising.

All the topical analgesics listed above are arnica-based, with few other ingredients. Arnica Montana is the premier homeopathic medicine for the treatment of shock and trauma to the muscle. These formulas come the closest to Pain Away's because they contain some of the essential homeopathic pain-reducing ingredients. Pain Away's formula, however, blends more ingredients than any other homeopathic topical analgesic on the market. This more inclusive formula gives the product wider applicability. Price-wise, Pain Away is more expensive than most of the competing homeopathic products, where prices are in the $5-$10 range for 2oz.-4oz. sizes. But, this is a value-priced market, so price is not a critical variable. Since Pain Away is very competitive on an ingredient/effectiveness basis, the critical factor is having the resources to promote the product.

Future Competition

As has been noted, the topical analgesic category, including natural ingredient, is rapidly influenced by new clinical studies and product innovations. There are three main sources of new competition:

• New ingredients and/or new innovations of existing ingredients. Examples are new products which employ the medicinal benefits of ammonium compounds. These products are designed to provide pain relief without the objectionable training room smells, burning sensations and stinging of abraded skin that are often caused by the majority of topical analgesics that contain menthol, methyl salicylate or capsaicin as active ingredients. Pain Away's formula has solved this sensation problem and is a less "high-tech" product, for which consumers are showing a preference.
• Companies currently in this market who could increase market share and become major players. Pain Away Ltd. is in this category.
• Chain drug companies may produce their own private label homeopathic products and corral a significant share of this growing market - much as they did in the non-homeopathic analgesic market. This scenario is more likely to happen as homeopathic companies expand the sales volume in this market and there are share points to be taken away by private labeling.

Pain Away Ltd. can be very competitive with the right promotional support.

Marketing Strategies

Increase market share by reducing market share of competitors. This strategy will capitalize on the market development to date and capture a share of markets held by existing pain-relieving topical applications. The key benefit is that conventional pain-relievers mask pain while Pain Away stimulates the body's own healing ability to directly battle an ailment. Another benefit is that homeopathic remedies have no known side effects while many pain-relievers, especially those ingested, have side effects. Neither will Pain Away interfere with any medication. This strategy requires extensive advertising in mainstream media, including infomercial, QVC (Pain Away already under review), 60 second commercial, cable TV, interactive TV, direct mail, independent sales reps, POP displays, and educational inserts/newsletters. One objective of planned controlled studies on the effectiveness of Pain Away is to use scientific evidence to help bridge the narrowing gap between natural and conventional medicine. Product studies will support this marketing strategy. In this context, the company will pursue preliminary inquiries from a favored vendor to use Pain Away in the workplace to study any reduction of lost work time and/or medical costs precipitated by repetitive stress injuries.

Expand a growing new market for alternative health care by positioning to lead this growing market. This strategy involves specialty catalogues (placed in 5 currently), placement on retail shelves of health food stores, educational product inserts/newsletters, media appearances discussing product, and independent sales reps. This strategy addresses the 89.1 million users of alternative health care.

The company has already been approached by two large Multi-Level Marketing companies. This strategy would involve creating private labels for a large customer. Of utmost consideration with this strategy is product identity and how this channel of distribution would affect it. This channel of distribution usually requires more price mark-up than the product would tolerate.

The company will create its own "competition" by developing private labels and/or separate companies to market to different niches.

Keep capital outlay to a minimum by licensing/franchising Pain Away to a brand-name company. This strategy would add value to the product in the form of brand name loyalty, manufacturing strength, and a strong sales/service force already in place. The company envisions its role in this type of strategic alliance as conducting scientific studies to increase the credibility of TPR and in developing new products. This strategy remains an option which could preclude other strategies under mutually acceptable terms.

Building on an initial order from a health product distribution company in Hungary, Pain Away Ltd. will penetrate the European market by targeting England and Germany, where homeopathy is an accepted form of treatment. This strategy would be developed only after a US market position was established.

Marketing Plan

The company is moving from start-up stage into its first growth stage. Market strategy to date can be succinctly described as selling "one jar at a time." Direct personal selling has been the mainstay in sales growth. This strategy has targeted any end-user willing to try the product. These early customers were reached through health care professionals and direct selling through state/county fairs, shopping mall space, health food store chains, and most recently lifestyle catalogues. As the company moves away from direct selling, a strategy which proved to be an excellent market test, into mass-marketing, identified market segments are being matched with appropriate distribution channels. The plan now is to expand and concentrate more on helping the consumer develop product preference by heavy advertising of the brand name, the benefits of the product, the ease of use, and the guarantee. Company expectations are that all advertising will be enhanced by results of controlled studies of product effectiveness.

The company intends to expand regionally, based on existing markets and consumer profiles (e.g., households from the South are likely heavy users of analgesics). The national market will only be tested by placement in catalogues with a distribution of 200 million. As regional sales grow and as the product gains recognition, then a national marketing strategy will take shape. Company management have begun discussions with a major marketing communications agency (Fortune 500 client list) who themselves approached Pain Away. The marketing and sales outline is as follows.

Marketing Function

• A complete review and analysis of the topical analgesic market.
• Utilization of Triad Groups conducted with the professional community and general consumers. Purpose is to identify professional and consumer preferences.
• Based on research, create a product identity.
• From product identity, establish professional and consumer strategic directions, which would affect product design, packaging, advertising, consumer promotion, and product publicity.
• Test both professional and consumer strategic direction via two more Triad Groups.
• Develop launch marketing plan with all elements and budget for both professional and consumer.
• Actual implementation of the plan to include product design changes, packaging, advertising, consumer promotion, display, and product publicity.

Sales Function

Utilize a sales organization enabling direct-call coverage on the top 25 customers, which generally account for 80% of retail sales, and broker-managed coverage for the remainder. Launch plan would include a national sales meeting and all necessary materials.

Professional

Concentrate on the pharmacist community via co-op direct mail. Pharmacist recommendation at the purchase counter does affect sales.

The production process takes place in a standard homeopathic laboratory where raw materials are blended. There are no significant health or safety risks involved. Production orders are processed by purchase order for finished product. Some raw materials are usually on hand but more are ordered against purchase order requirements. Jars are ordered from a separate manufacturer and sent to the homeopathic laboratory to be filled, packaged, and shipped to Pain Away Ltd., where fulfillment is done.

The homeopathic laboratory has the capacity to fill all projected orders. As orders increase, Pain Away management will consider using a fulfillment service and more drop-shipping to wholesale customers. Cost of goods is estimated at 18% of gross sales. This figure has been consistent throughout production to date and is based on the complete production cycle.

There is no backlog.

Production Characteristics

The production process does not require any specialized or proprietary machinery. The critical factors in the production process are the highest quality of raw materials and the incubation process, which assures a stable finished product. Water is added to a base of vegetable/plant emollients. The eleven active ingredients are then mixed into the emulsion, which incubates for about 48 hours in large vats, while monitored for any fungal invasion. The finished product is then lab-tested for potency, which is done by lot number (the company gets lot samples). Filling is currently done by gravity-feed. The manufacturer might advance to computerized filling. One batch is 500 gallons. Lead time from order to packaged product is 4 weeks. Only a skilled and experienced manufacturer can produce the formula. Even other homeopathic manufacturers not familiar with a cream-based product would have difficulty with the production process. General topical analgesic manufacturers would need to become familiar with the raw materials and the production process in order to blend Pain Away's eleven active and ten inert ingredients. The company currently has one back-up manufacturer, which has never been used.

Labor Force and Employees

The company administrative staff consists of 5 people (recently reduced by 3) including the 3 officers. The two employees are paid an hourly wage. The staff are not unionized and there is no expectation of such. The labor supply in the region is more than sufficient to meet all future staffing needs. The sales force is comprised of independent agents who are paid on commission.

Currently, the laboratory procures all production materials. There are no shortages of key components, and multiple sources are available.

Subcontractors

All production is sub contracted out. Only fulfillment and shipping are done in-house. The company has formed a strong working relationship with Herbal Laboratories, which is the key subcontractor. Although management has selected a back-up manufacturer, the existing relationship with Herbal Labs has been more than satisfactory, so no change is foreseen. Other subcontractors supplying jars, labels, and boxes are used based upon price and service and can be replaced.

Standard office equipment is used for administrative functions. All production equipment at Herbal Laboratories is new and there is nothing that would cause production to be stopped for any appreciable time.

PROPERTY AND FACILITIES

The company facility is a single-story 1,950 square foot, cement block structure on about a two-acre cleared lot that is leased in one-year increments. The facility is located in northern Dutchess County, NY. All necessary commercial and industrial infrastructure is in place. The facility is easily accessible from major thoroughfares. The general area has been and is recovering from the closing of 2 large industrial facilities, so there's been anoticeable decline in property values. There is, however, a regional effort to re-direct the area to rely more upon small and entrepreneurial business. Management plans to purchase the building in order to add an appreciable fixed asset and to reduce expenses. The structure is easily expandable, so the company will not have to move during its critical growth stage.

PATENTS AND TRADEMARKS

Active homeopathics are not patentable. Management is exploring establishing a trademark and a formula patent.

RESEARCH AND DEVELOPMENT

The three principals have invested collectively $100,000, which has been capitalized. Plans for the immediate future include forming a research alliance with a university, hospital, or research group in order to develop a protocol for applying the "rigorous scientific standards" against which the effectiveness of Pain Away can be proven. Management has projected R&D expenses at $ 30,000 for the next 12-month period. These expenditures are intended for controlled studies proving effectiveness, and for continuation of developing applications for animals. Management is sales-marketing oriented and does not want to develop only a research lab. Any R&D will be designed to enhance sales and profits. Company management is currently investigating an SBIR grant.

There are no particular federal, state or local laws/regulations that affect the conduct of business. The manufacturer meets OSHA requirements, as does the Pain Away administrative facility. The FDA regulates homeopathy as an OTC non-prescription medicine. Pain Away's ingredients are in total compliance with FDA standards. Mr. Peale cultivated a working relationship with FDA representatives during the initial research and wisely intends to sustain such.

Product liability insurance is underwritten. A buy-sell agreement among officers exists but is not yet backed by insurance. Key employee insurance is also yet to be written.

All taxes are current. The company pays standard payroll, Social Security, and corporate taxes. The product is sales tax exempt in many states.

Company principals first formed an S-corporation under the name Peale Inc. The realization of the likelihood of international sales prompted management to form Pain Away Ltd. as the operational company. Peale Inc. serves a limited partnership which was formed to attract investors. Both companies are run by the same management team. All R&D is done through Peale Inc. There is comingling of funds. This proposal seeks financing for Pain Away Ltd. Return on the investment will derive from the sale of the product Pain Away itself and any other products which the company sells.

Pain Away Ltd. is a member of the Homeopathic Manufacturers Association. The officers were invited to participate in an annual meeting of the newly formed FDA committee on natural medicines. This committee works on the bases for regulations, compliance, and claims for the natural ingredient industry, covering vitamins, herbs, and homeopathy.

Management subscribes to the following publications:

• Homeopathy Today
• Natural Foods Merchandiser
• American Health
• Prevention Magazine
• Let's Live
• New England Journal of Medicine letter

Directors and Officers

A board of directors will be developed in the near future. There is interest from the medical, nutritional, and professional sports communities, as well as from a local bank. Officers are:

Robert Peale - CEO Alana Curtis - President Ryan Lemon - Vice-President, Marketing

Profit and loss responsibilities are shared by the officers.

The officers are primary key employees (backgrounds in executive summary). Other key employees include:

Key Employees

Leslie Ottaviani - bookkeeper and office manager - known by management for 5 years and described as "a dedicated innovator with a true grasp for details." She has experience supervising 20 employees in the accounting department of Worldwide Airlines and has worked as an independent bookkeeper for several companies in Hudson Valley, NY.

Julia Allen - administrative assistant - known by management for 6 years and described as "having people and problem-solving skills and works incredibly well under pressure." Her background includes sales in a successful business which included business consulting.

Remuneration

Accountant and Banker

All other fees paid on an ad hoc basis. Different attorneys have been used on an ad hoc basis (finance closing fees will be paid by the company).

Principal Shareholders

Proposed Financing

Management is willing to negotiate any structure which suits the investor. The company is seeking an equity investor. Management will provide a seat on the company's board of directors. Ongoing reports of key ratios, profit-loss statements, balance sheets, and annual audits would be provided to the investor. It is management's intent that the investor will enjoy returns on investment in excess of that of alternative investments, as a privately held company, while providing investor liquidity of his investment by taking the company public at its earliest opportunity.

Capital Structure

The existing capital structure includes a $50,000 unsecured line of credit with Poughkeepsie National Savings Bank. This line of credit was just brought to maturity in 1/96 for a 30-day period, at which time the line was renewed. If the current financing proposal is accomodated, then the line of credit can be increased.

Additional financing to date has derived from the sale of limited partnerships offering $.01 per 3.7 oz. jar royalty for every $1,000 invested. Each limited partner has been given the right to convert his/her capital investment into common stock when the company goes public, or, to receive back his/her original capital investment when the company goes public. Total amount of financing raised through the limited partnership is $100,000.

As mentioned earlier, officers have collectively invested about $100,000 in the company, mostly through the R&D phase. Officers' "sweat equity" is immeasurable.

As stated in the executive summary: Advertising & promotion campaign - $1,200,000 (see below); Market research - $300,000. The company anticipates the need for follow-on financing after 24 months of business.

Management intends to preserve cash flow by factoring much of the receivables. With the current lead time of 4 weeks, however, some capital may be used to increase merchandising inventory in order to fulfill initial large orders. It is hoped that any follow-on financing can and will be debt financing, serviced by cash flow.

The following table sets forth the capitalization of Pain Away Ltd. as of 12/31/95 and as adjusted to reflect the proposed sale of common stock.

Dilution: The net tangible book value of the company as of 12/31/95 was minus $1,673 per share. Without taking into account any other changes in such net tangible book value after 12/31/96, other than to give effect to the sale of 60 shares (proposed 30% equity share) hereby, the pro forma net tangible book value of the company on 12/31/95 will be $5,827 per share, representing an immediate dilution of $13,597 per share to new investors.

Management recognizes that this proposed financing implies a large premium value on the existing equity and so will negotiate any other conditions which would induce the investor to make the investment.

At the time of the company's IPO, limited partners who opt for common stock will receive their shares from the officers' share of owned stock. The negotiated ownership held by the investor will not be further diluted.

Investor Involvement

Management seeks a close working relationship with the investor. The investor will be given one seat on the board of directors. Management would solicit consultations (for a fee) on financial matters, or any other area of investor expertise (e.g., planning, management development), but voting power is not an option. Fees will also be paid for any future financing and/or profitable business connections arranged by the investor.

Limited Operating History

Even though management feels that the company is at first-stage expansion, it is definitely still an early-stage company. Two obvious risks inherent in early-stage companies are undercapitalization and poor liquidity. Management has capitalized the business operations to date well enough to have developed the product and identified penetrable market segments. The current proposed financing will provide enough capital to handle the anticipated growth.

Limited Resources

Management believes that it has the resources to continue at the present pace of business. An anticipated increase in sales through advertising media such as QVC , regional/national catalogues, retail outlets, and some European distribution can be financed by factoring. These "bootstrapping" approaches have sustained the company to date and will accommodate slow growth. Management believes, however, that more rapid expansion is desirable in order to penetrate its identified market segments. More rapid expansion requires more resources.

Limited Management Experience

All officers have successful backgrounds in marketing. Additional experience in manufacturing/distribution has been gained in the past nine years of product development. Management has consistently shown a willingness to leverage themselves with accomplished professional consulting relationships. The company culture is one which reinforces sharing of expertise with mutual benefit to all concerned.

Market Uncertainties

Any consumer product business is subject to the changing preferences of the marketplace. As presented in the marketing section of this proposal, the target markets are showing substantial growth, which limits uncertainty. There is currently a growing consumer preference for homeopathic topical remedies. More uncertainty is evident when considering competition, but can be made tolerable by on-going research and analysis.

Production Uncertainties

The only uncertainty at present is whether or not the lead time (4 weeks) from purchase order to finished product can consistently be reduced. This uncertainty is of material concern as sales increase. Herbal Laboratories is a sound company with a promising long-term future and has always been customer-friendly, so no more serious uncertainties exist at present. Management believes that vertical integration of manufacturing is feasible in the long-term but is not practical in the near-term.

Liquidation

In the event that liquidation becomes necessary, management believes that the most value could be realized from the sale of the product formula itself. The formula is not patented, so valuation remains uncertain. However, the sales history, along with the testimonials attesting to the effectiveness of this "ready-made" product, should determine value. Office equipment would yield limited value, and unless the company building was purchased prior to liquidation, no value would be realized. Management believes that the company can and will generate increasing value in the near future, evidenced by increasing sales.

Dependence on Key Management

At present, CEO Robert Peale is considered the primary key manager/officer. His knowledge of the product ingredients, his history of public appearances promoting the product, his increasing recognition by the health community as an expert in natural medicine, and his charisma as a business professional highlight his key role. Managerially, the other officers are thoroughly competent and could manage the company and market its products without Mr. Peale. At this critical early stage, however, the product needs an identity and a market position before the loss of any key managers could be overcome. Once the premier product is securely launched and the product line is expanded, the loss of any officer could be absorbed by continued proper management of the company. Management believes that such a development is not far off, once the company is properly capitalized. Until such time, key person life insurance will be purchased.

What Could Go Wrong?

Upgraded advertising campaigns could not lead to any substantial increase in sales. This problem can be avoided by using experienced advertising/marketing consultants who have familiarity with the targeted markets. Furthermore, properly designed test runs on any advertising campaign would provide objective indicators of expected returns. Capital investment in advertising should be gradual and progressively based upon certain expected levels of return.

Stronger competition could capitalize on and stall Pain Away's early success by replicating the product and its marketing strategy. This problem can be solved in two ways: First, with proper capitalization, Pain Away can make an entry into targeted markets rapidly and with enough strength to grab market share. Keeping market share can be easier than getting it. This market requires extensive advertising. Increasing market share could mean an increasing advertising budget. An increasing advertising budget can easily reduce profit margin, so strategic planning is required. The second way to solve the competition problem is in the formula itself. Management will seek to patent the formula. The nature of the homeopathic ingredients is likely to inhibit any mainstream non-homeopathic company from replicating the product. Acquisition of a homeopathic company would make more sense. Narrowing the competition, then, to other homeopathic companies gives Pain Away more of a fighting chance, since its formula is more sophisticated and user-friendly than any homeopathic topical analgesic on the market.

Governmental controls could conceivably impede sales. This problem is unlikely because the ingredients are already FDA-approved. Furthermore, management's participation in the FDA committee to develop regulatory standards for the natural medicine field would provide early warnings of any such prohibitory controls.

The company could be controlled by non-investor stockholders. This problem is not likely to develop because the management team would hold a majority. Management is dedicated to the principles of increasing value and profits and is confident that its efforts will be in concert with those of the investor.

RETURN ON INVESTMENT ANDEXIT

Public offering.

Management plans for an IPO in 5-7 years. The investor's shares would be sold to provide the targeted return on investment. Should there be no public market, then a buy back would occur.

Management will negotiate a buy back formula with the investor and will target milestones in planning for this possibility. Management aims for returning 6 times the original investment in five years.

ANALYSIS OF OPERATIONS AND PROJECTIONS

The business has not shown a profit since sales activity began in May 1994. This lack of profit is not unusual for an early-stage company. Losses were incurred in the start-up phase, where the objective was to get consumers to try the product. Gross profit margins have remained stable, however. Management focus was targeted on getting professionals and consumers to try the product in order to collect anecdotal evidence and testimonials of its effectiveness. Not enough focus was on asset management, as evidenced by a low return on assets ratio (p.32). Now that the product has gotten some recognition, especially in professional circles, the focus will shift toward mass marketing. Management intends to improve inventory management by using factoring of receivables in conjunction with JIT inventory control. As sales volume increases, drop-shipping from plant to wholesale customer, will also be arranged.

Balance Sheet

Monthly Income Statements 1995

Income Statement - 12/31/95

Key Ratio Analysis

THIS PORTION OF PAGE INTENTIONALLY LEFT BLANK SEE NEXT PAGE FOR PROJECTED CASH FLOW TABLE

Projected Cash Flow

Projected Annual Financial Statements

Assumptions

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Online GMP Courses with Certificate Planning and Designing a Pharmaceutical Manufacturing Facility Design overview of pharmaceutical facilities. Location and access to transportation and utilities Climate and environmental conditions Facilities layout and equipment requirements Security and safety considerations Design Principles for Pharmaceutical Facilities Environmental impact of pharmaceutical facilities, facility layout and operation. Location: The location of a pharmaceutical plant should be based on the availability of resources and the proximity to customers. The plant should also be located in an area with low temperatures and good air quality. Extension: Facilities should be designed with an extension in mind, in order to accommodate future growth. This includes planning for manufacturing areas, storage areas, and utility rooms. Design: Pharmaceutical plants should be designed using best practices in order to minimize risks and ensure safe and effective production. 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Security and Safety in Pharmaceutical Facilities Implementing effective security measures to protect against unauthorized access and theft. Designing adequate emergency response plans to address potential accidents or incidents. Ensuring that the facility is properly ventilated to avoid exposure to harmful gases and fumes. Providing dedicated space for storage of hazardous materials. Creating a safe work environment for employees by providing appropriate equipment and training. today = new Date() if ((today.getHours() >=9) && (today.getHours() today = new Date() if ((today.getHours() >=18) && (today.getHours() =0) && (today.getHours() .reverse { unicode-bidi: bidi-override; direction: rtl; display:none;} Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips. .moc.enilediugamrahp@ofni :liamE Need Help: Ask Question No comments: Post a comment. Please don't spam. Comments having links would not be published. Popular Categories Jobs Follow Pharmaguideline Like Follow Follow Follow Follow Install Join Subscribe PHARMACEUTICAL DOCUMENTS Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more... Discussion - Latest Topics Advertise here, get app for news updates. Pharmaceutical Updates ✔ Worldwide Regulatory Updates ✔ Pharmaceutical News Updates ✔ Interview Questions and Answers ✔ All Guidelines in One Place Recent Posts About pharmaguideline, our policies. ⛔ ✋ Welcome! It looks like you are using Ad Blocker on your Browser. But without advertising, we can not keep making Pharmaguideline awesome. To continue reading you need to turnoff adblocker and refresh the page. I understand, I have disabled my ad blocker. Let me in! Pharmaceutical Distribution Business Plan [Sample Template] By: Author Tony Martins Ajaero Home » Business ideas » Healthcare and Medical » Pharmacy Are you about starting a pharmaceutical distribution business? If YES, here is a complete sample pharmaceutical distribution business plan template & feasibility report you can use for FREE . Okay, so we have considered all the requirements for starting a pharmaceutical distribution business. We also took it further by analyzing and drafting a sample pharmaceutical distribution marketing plan template backed up by actionable guerrilla marketing ideas for pharmaceutical distribution businesses. So let’s proceed to the business planning section. The pharmaceutical distribution companies can be referred to as companies that stand in the gap between drug manufacturing companies and retailing pharmacies as well as end users. This is an industry that is recession proof and so any enterprising entrepreneur can go into this business. Suggested for You Retail Pharmacy Business Plan [Sample Template] Drug Prescription Delivery Business Plan [Sample Template] What is the Best Way to Rob a Pharmacy? [How to Prevent It] How to Make your Pharmacy More Efficient and Profitable How Much Profit Does a Pharmacy Make on a Prescription? To however start this kind of business, one would require knowledge of drugs and how distribution in this industry works. One thing that must be done before starting this kind of business is to hire a business consultant who understands the industry and has knowledge on this kind of business and who would look into the business concept and determine if the business would survive and make profit as it should. Another thing that would be required when starting this business is a comprehensive business plan. Writing a business plan is vital especially if you intend to approach an investor or a financial institution for a loan. Writing a comprehensive business plan might be a bit intimidating; however there are options available for any serious entrepreneur, which is either hiring a business plan writer to write a business plan or going online to source for free templates. Below is one of such templates, a sample pharmaceutical distribution business plan; A Sample Pharmaceutical Distribution Business Plan Template 1. industry overview. This is an industry that covers the wholesale of pharmaceuticals as well as medical goods. These drugs or medical goods are distributed to specialist retailers, hospitals, retail pharmacies, doctors, as well as specialist medical practitioners. The pharmaceutical distribution industry generates revenue of over $30 billion and has a growth that has been tagged at 0.6% from 2012 to 2017. The industry is one that has more than 2,300 businesses employing nearly 67,000 people. The industry is one that has undergone a great number of changes within the past five years with most of the players in the industry facing challenges; which is because most of those in the industry have moved away from the traditional wholesale model. The changes that have occurred in the industry has been due to the fact that there are structural changes occurring as external players like the supermarket has entered into the provision of pharmaceutical services. Most of the changes in this industry came in during 2005, which was as a result of partial deregulation in the community pharmacies that came into effect in that year. There has been progress in the industry over the last decade especially with the introduction of improved technologies and developed infrastructures. Globally in 2014, the industry was worth $1 trillion; which was an increase from 2013, where the industry was valued at $980.1 billion. The United States and Canada contributed 41% of sales in the industry. In this industry, smaller pharmaceutical companies pose no direct threat to larger pharmaceutical distribution companies. This is because smaller companies eventually sell to larger pharmaceutical distribution companies years along the line. The industry is stiff with competition as there is a strong competition amongst high-level workers and leading researchers. 2. Executive Summary Dove Pharmaceutical Distribution Company is a standard drug distribution company based here in Louisville – Kentucky, USA that will serve our target market which constitutes smaller retail pharmacies as well as healthcare professionals. We are in business to offer generic and branded drugs to our customers here. Our vision is to ensure that we are the preferred pharmaceutical distribution company in Louisville – Kentucky through our supply of quality drugs as well as offering the best prices for these drugs to our customers. Our aim is also to be the leading brand in the industry by the year 2022. Our distribution channel is of the best standard practice and we have closed all loopholes that will not allow for a loose system of distribution. Our storage area is well ventilated and secured which means that our drugs are kept in a well ventilated area and free of dust and dirt. We have deployed structures and plans in all our distribution processes in order to ensure that we remain abreast of all technological developments in the industry; this will ensure that we are able to give our customers our very best when it comes to serving them. We are committed to bringing in competent and professional employees who have the knowledge and expertise necessary to bring our company to its desired level. We intend to ensure that our employees undergo training that will make them become more productive and also enhance their skill set. Our employees will be well paid in comparison to other employees in similar start-ups such as ours in the industry. Asides from being well paid, our employees will undergo continuous assessment in order to ensure that those who perform well are well promoted or given incentives. We intend to ensure that we offer our customers excellent service, the best in the industry. Our customer care executives have been well trained and are updated as regards the trends in the industry in order to better serve our customers. Finally, our owner, Steve Bannon who is an entrepreneur has an MBA degree from Harvard and Victor Trump has been a sales representative for major drug manufacturers in and around Kentucky. Both men have over 30 years of experience and have the professional experience to ensure that the company gets to its desired level. 3. Our Products and Services Our aim at Dove Pharmaceutical Distribution Company is to be able to supply both branded and generic drugs and other medical accessories to all our customers here in Louisville – Kentucky and in locations around the state as well. We are also established to make profit and in order to ensure that we generate enough revenue to make profit; we intend to create multiple sources of income, by offering other services as well as creating a franchise for those who intend to use our drug distribution model when starting up rather than start from the scratch. All our sources of income will be under all the legal and permissible laws of the united states of America. Therefore, some of the products and services which we intend to offer our customers are; Sale of branded and generic drugs in wholesale to chain pharmacies, local pharmacies and internet pharmacies Sale of medical related equipment Advisory services 4. Our Mission and Vision Statement Our vision is to be the preferred pharmaceutical distribution company in Louisville – Kentucky through our supply of quality drugs as well as offering the best prices for these drugs to our customers. We also hope to be a leading brand in the industry by the year 2022. In order to achieve our vision, we intend to ensure that we liaise with only trusted pharmaceutical companies as well as with doctors and other healthcare professionals in order to ensure that we source for as well as supply quality drugs to our customers. Our Business Structure Having a strong business structure is very important for any business that intends to be able to run smoothly with as less hitches as possible, because a sound business structure embodies the corporate values of the organization. This is why we are taking our business structure very seriously here at Dove Pharmaceutical Distribution Company and intend to build one that would take our business to where we intend it to be. We intend to employ competent and professional employees into our pharmaceutical drug distribution company, especially those that understand the industry and have the right knowledge on how to ensure that we attain our desired goals and objectives as a business. We would continually ensure that our employees are well-trained so that this could enhance their skills and improve productivity for our business. We would also ensure that these employees understand our corporate values as a business and are committed to our vision. Furthermore, we intend to ensure that the employees are well paid and given a welfare package that is the best across similar start-ups such as ours in the industry. Therefore, the business structure which we intend building at Dove Pharmaceuticals Distribution Company is; Chief Executive Officer Human Resources and Admin Manager Purchasing Manager Inventory Manager Accountant/Cashier Customer Service Executive Marketing and Sales Executives Truck Driver Security Guard 5. Job Roles and Responsibilities Makes strategic decisions on behalf of the company Reviews strategies made for the company and ensure that ineffective policies are tweaked Negotiates with high level clients on behalf of the company Human Resources Manager Ensures that the right employees are sourced for and hired on behalf of the company Conducts orientation training and induction for new staff In charge of staff welfare packages and assessment trainings Sources for reliable drug vendors and manufacturers on behalf of the company Prepares and reviews contract documents for these vendors and drug manufacturers Ensures that the correct drugs are sourced on behalf of the company In charge of ensuring that the correct stock is recorded on behalf of the company Monitors the drugs taken out of the company Ensures that depleted stock are replenished as soon as possible Prepares all financial information and statements on behalf of the company Ensures that correct tax document and information are submitted to the tax authorities  Drafts the budgets on behalf of the company In charge of answering inquiries and helping clients with orders on behalf of the company Ensures that complaints from clients are promptly resolved Keeps an accurate database of customers on behalf of the company Conducts marketing survey that will ensure that we gain new markets Conducts direct marketing on behalf of the company Ensures that the premises are kept clean at all times Carries out thorough cleaning of the drug storage area to keep it clean from dust Ensures that dwindling cleaning supplies are re-stocked as at when due Ensures that products are driven to accurate destinations in a timely manner Inspects the on-loading and off-loading of drugs to and from the delivery truck Carries out light maintenance repairs on the trucks Ensures that the premises are secured and safe especially after business hours Monitors the surveillance camera to check incoming and outgoing products and personnel Reviews security procedures and ensure that they are continually updated 6. SWOT Analysis In order to ensure that we build a standard pharmaceutical distribution company here in Louisville – Kentucky, we hired a reputable business consultant to look at our business concept and know if we are able to survive in this business environment and how we would be able to fare against our competitors in the industry. The business consultant took a look at our strengths, weaknesses, opportunities and threats that we were likely to face here in Louisville – Kentucky as well as in the whole of the United States of America as a whole. Below is the result that was gotten from the critically conducted SWOT Analysis on behalf of Dove Pharmaceuticals Distribution Company; Our strength lies in the fact that we would be offering quality branded and generic drugs to our customers in order to keep up with our brand image. We also are located in a strategic location here in Louisville – Kentucky and have a competitive advantage over our competitors. Also, we have hired several competent and professional employees to ensure that we are able to attain our desired goals and objectives. Also, asides from offering quality drugs to our customers, we also will offer several other services to our various customers. Finally, the owners of our company have the expertise and knowledge required to ensure that we attain our goals and objectives. There are stringent regulations for this industry as players have to abide by a huge number of regulations put forth by the government. There are also enough competitive players in the industry that we will have to compete with which might weaken our position in our location. Opportunities Most of the people who use more drugs are newborn babies and the baby boomers asides those who are sick and there are increasing number of baby boomers in existence which means that there will always be a demand for drugs. Also, the increase in medical insurance has seen the increase in those who can purchase drugs for use. Every business experiences threats every now and then and so every entrepreneur that intends to start or run a business should be prepared to face threats that would arise during the course of business and ensure that there are proactive measures to combat any threats. Therefore the threats that we are likely to face during the course of starting this business are; governmental policies which might stem from tightening monetary policies that would affect the pharmaceutical industry. Another threat might be from increase in raw materials and labor costs which would affect the costs of our drugs; however we have put measures in place to cushion the effect of the rising costs. 7. MARKET ANALYSIS Market Trends The pharmaceutical distribution business is one where companies engage in the distribution of drugs at wholesale and retail level to customers either for end use or for further distribution to others in the drug distribution business. This market is one that is very important as it brings the drugs closer from the drug manufacturers to the consumers and or retailers. Every pharmaceutical distribution company that intends to operate in a standard and efficient way must be willing to ensure that they have both branded and generic drugs ready for customers and ensure that the drugs are of a high quality for the consumers. This is an industry that is very vital as everyone regardless of age requires drugs at every point in time, this means that there is always demand for the products in this industry and so it is an industry that can never be affected by economic downturn as people would always use drugs no matter what. The trend in this industry is that people can come in to get drugs for themselves or have it sent to where they live as long as all documentations have been signed for and approved. Also, depending on the kind of drugs gotten, most end users usually pay for high end drugs through their insurance. Lastly, technology has come to play a huge role in the pharmaceutical industry as research for drugs have become quicker amongst drug manufacturing companies ensuring that customers and healthcare professionals do not have to wait a very long time for drugs that would alleviate their ailments. Asides, from research and development, technology has ensured that drugs are now distributed more efficiently and that there is more accountability for the distributors in order to stem the abuse of drugs. Technology has also helped drug manufacturing companies advertise the benefits of their drugs for their potential and existing customers making it easy for pharmaceutical distribution companies to be able to have quick turnovers for certain drugs that have received massive advertisement and publicity. 8. Our Target Market Even though almost everyone uses drugs which should make the target market unlimited, the target market for pharmaceuticals distribution companies is actually more limited especially as huge drug distribution companies rarely serve end user customers. However, to help us understand and know who our target market are, we have conducted a market research that should enable us strategize accordingly depending on our location and other factors that would allow us penetrate the target market. In other words, the market research we have conducted would enable us know who our target market are and what they would expect from us in terms of service, and how best we can serve them. Therefore, from results, we are in business to distribute our drugs to the following groups of people; Retail pharmaceutical companies Healthcare clinics Non-governmental organizations Internet pharmaceutical companies Specialist retailers Our competitive advantage Our reason for starting the pharmaceutical distribution business is so as to ensure that we build a business that we become the preferred pharmaceutical distribution company in Louisville – Kentucky through our supply of quality drugs as well as offering the best prices for these drugs to our customers. Our aim also is to be the leading brand in the industry by the year 2023. We are going to be a pharmaceutical distribution company where our competitive advantage will be based on superior pricing, which will arise from us offering quality drugs at comparable low prices for our different clients. We would do this by ensuring that we operate a low overhead. This we believe will stand us out from our competitors. Another competitive edge that we have against our competitors is the fact that we have hired experienced and competent employees who are professionals and understand the industry as well as our core values and therefore know how well to ensure that we attain our desired goals through their high level of commitment and productivity. Another competitive advantage we have is that we employ the use of technology in ensuring that we serve our customers better. This results in better and efficient way of dealing with orders and delivery of our drugs. Finally, we have the best management team that will ensure that the business attains its intended goals and desires through effective communication and implementation of the company’s values to our customers. 9. SALES AND MARKETING STRATEGY Sources of Income Dove Pharmaceutical Distribution Company has been established with the aim of generating revenue and making profit in the pharmaceuticals industry here in the United States of America. Our intention at generating revenue is to ensure that we offer a variety of products and services to our different clients here in Louisville – Kentucky. We intend to generate revenue for Dove Pharmaceutical Distribution Company through the sale of these products and services; 10. Sales Forecast The industry is one that would always see a demand as people of all ages use drugs for various ailments and purposes. Our positioning in Louisville – Kentucky is very vital to our growth and since we chose a strategic location, we are quite optimistic of meeting our target revenue and achieving a profit margin in the first year of business that will not only sustain the business but grow it as well. In being able to carry out a sales projection for our business, we conducted a critical survey of the industry in order to analyze our chances in the industry. The critical analysis took several assumptions into consideration especially those that are peculiar to similar businesses such as ours in the drugs industry. Below are the sales projections for Dove Pharmaceutical Distribution Company here in Louisville – Kentucky; First Fiscal Year-: $1,500,000 Second Fiscal Year-: $3,000,000 Third Fiscal Year-: $6,500,000 N.B : This sale projection is done based on several factors that are obtainable in the industry such as the fact that there won’t be an arrival of a major competitor in our same location, and also that there won’t be an interference of governmental policies in our industry. Should there be any change either positive or negative in any of the factors, it would lead to an increase or decrease in the above projected figures. Marketing Strategy and Sales Strategy Marketing is a very important aspect of any business either start-up or existing business as it helps generate the revenue that will sustain the business. In order to ensure that we draft the right marketing strategies for our business, we intend to conduct a thorough market survey that would allow us know who our target market is and penetrate the business as well. For this reason, we have hired a marketing consultant to help us conduct the market survey by using detailed information that we would use to be able to attract the intended number of customers to our pharmaceutical distribution business here in Louisville – Kentucky, and around the whole United States of America. Most of our marketing strategies would be based on advertisements that are targeted towards the right audience and ones that will appeal to the sense of values of our customers. Asides from generating revenue for our business, our marketing strategies would also generate and increase awareness for our pharmaceutical distribution business, here in Louisville – Kentucky. We would also ensure that we empower our marketing and sales team in such a way that they would be able to draft marketing strategies that would align with the corporate values and principles of Dove Pharmaceutical Distribution Company. In summary, below are the marketing and sales strategies that we will adopt at Dove Pharmaceutical Distribution Company in order to generate revenue for our company; Ensure that we align with several drug manufacturers, doctors and healthcare professionals and other stakeholders in the industry in order to introduce our pharmaceutical distribution industry Throw a grand party during our launch in order to generate interest and awareness for our pharmaceutical distribution company Engage in direct marketing and sales to our target market Ensure that we place adverts in local and national newspapers, as well as on radio and television stations Ensure that our pharmaceutical distribution business is listed in online and offline directories Use social media platforms such as Facebook, LinkedIn, Twitter and Google Plus in order to raise awareness and market our pharmaceutical distribution business Pass out handbills and fliers in conspicuous places in order to market and raise awareness for our business 11. Publicity and Advertising Strategy Every business that is established to generate revenue and make profit does so in addition to be able to favorably compete with its other competitors either in the same environment or in other strategic locations that would have an impact on its own business. Drafting publicity and advertising strategies is very important for any business that intends to survive in the business environment. We intend to hire a reputable brand consultant here in Louisville – Kentucky, who understands the market and knows the industry so well so that he could help us draft strategies that would positively promote our pharmaceutical distribution company to existing and potential customers here in Kentucky and around the United States of America as well. Therefore, some of the publicity and advertising strategies that we would adopt at Dove Pharmaceutical Distribution Company are; Ensure that we increase our awareness in the local community by sponsoring relevant community programs Install our billboards in strategic and conspicuous locations in and around Louisville – Kentucky Ensure that we place adverts in local and national newspapers and on radio and television stations Ensure that we distribute fliers and handbills in target locations Use our social media platforms – LinkedIn, Facebook, Google Plus and Twitter – to positively promote our business Sponsor weekly or monthly press releases on the benefits of pharmaceutical distribution companies as well as other information that would benefit the target market 12. Our Pricing Strategy In determining the right prices for selling our drugs, we intend to take so many factors into cognizance. The factors we intend to look at that will help us determine what prices to set for our drugs are; overhead costs , operating costs, as well as what prices our competitors are offering similar drugs for. We will ensure that the prices for our drugs remain competitive enough in order not to chase away customers. Due to this, we intend to offer a discount on the prices of our drugs especially to customers especially those that pay for the drugs out of their pockets without using insurance for the first 3 months in operation. Due to our calculations, we are sure that we would be able to survive on low margins for the three months that we would be offering these discounts to our existing and potential customers here in Louisville – Kentucky. Payment Options Ensuring that our customers have different options when it comes to paying for their drugs is very important to us and so we have come up with different payment options platform that will suit all our different types of customers. Therefore the different payment options we intend to offer our customers here at Dove Pharmaceuticals Distribution Company are; Payment via cash Payment via Point of Sale (POS) Machine Payment via online payment portal Payment via Insurance Payment via check Payment via credit card The above payment options are ones that were carefully chosen for us by our bank and will work without hitches of any sorts to our various customers. 13. Startup Expenditure (Budget) Every business needs to lay out a breakdown on how it intends to spend its initial capital and what it would spend it on. The pharmaceutical distribution company is one that requires a huge capital especially in buying the drugs needed for distribution on a large scale, buying a delivery truck, leasing a facility and paying employee salaries and utility bills. Therefore the key areas where we intend to spend our start-up capital are; Total business registration fee in the United States of America – $750 Other legal expenses (licenses and permits) and software (accounting, admin, drug, and other software pertinent to customers) – $5,250 Leasing of a huge facility for at least two years and renovation of the facility – $300,000 Cost of hiring a business consultant – $20,000 Insurance coverage (workers’ compensation, general liability) – $5,000 Operational cost for the first 3 months (employees’ salaries, payment of utility bills) – $200,000 Marketing promotion expenses (For grand opening ceremony as well as general marketing expenses) – $10,000 Other start-up expenses (stationery, computer, phones, cash machines, scales for shipping) – $10,000 Cost of start-up inventory (drugs, packaging materials, assorted bottles and shipping boxes) – $500,000 Storage hardware – (shelves, bins, signage) – $3,000 Cost of purchasing two delivery trucks – $400,000 Cost of launching a website – $1,000 Cost of throwing an opening party – $5,000 Miscellaneous – $20,000 From the above breakdown, we would need an estimate of $1,180,000 in order to successfully start up and operate our pharmaceutical distribution company here in Louisville – Kentucky. It should be noted that the above amount includes employee’s salaries, leasing of a facility as well as purchasing of inventory and delivery trucks. It should also be noted that most of the items purchased will be used for more than a year and can be termed as assets. Generating Funding / Startup Capital for Dove Pharmaceutical Distribution Business Dove Pharmaceutical Distribution Company is a business owned and operated by two partners, Steve Bannon, an entrepreneur, who has an MBA degree from Harvard and Victor Trump, who has been a sales representative for major drug manufacturers in and around Kentucky. The two men intend to grow a business that is of high standards and have therefore decided to seek for start-up capital from the below sources. Therefore the areas where they intend to seek for capital are; From personal savings and sale of stock Apply for loan from bank Seek loan from private investor N.B : From personal savings and sale of stocks, we were able to generate the sum of $230,000 . We sought for a loan of $650,000 repayable at 3% interest in 5 years from our bank that has been approved as all documents pertaining to the loan have been signed and we are told to expect the amount in our account anytime soon. Finally, we have sought for a loan of $300,000 from a private investor who is asking for 3% equity in return. He has also offered to mentor us in certain areas. 14. Sustainability and Expansion Strategy No business is established with the intention of failing or not growing to a particular level. Our business is no different and our intention to draft sustainability and expansion strategies is to ensure that we remain in business for a very long time. In this regard, we intend to hire competent employees; we supply quality brand and generic drugs, and also ensuring that we retain a high number of our existing and potential customers. Hiring competent employees is very vital as the employees are the ones who take the business to its desired goal, this is why it is very important to hire those who are attuned to the company’s goals and also understand it and are committed to ensuring that they help bring the company to where it is supposed to be. Our employees will be well trained so that the productivity will be increased for the company. We will also ensure that our employees are not only well paid with great welfare packages but we will also ensure that they work in an environment that is deemed conducive and safe. Our aim is to ensure that we supply quality drugs that are either branded or generic to our various customers. We know and understand the importance of ensuring that our brand is associated with the distribution of drugs – either branded or generic – that are of high quality, and so we would liaise with drug manufacturers and healthcare professionals as well as other stakeholders to ensure that we are aware of what drugs to get and distribute for our various customers in the United States of America. Finally, we know how important our customers are to us and so we intend to ensure that we retain a high level of our customers. We intend to offer our customers excellent service the kind that is unrivalled across the industry. Also, our repeat customers will receive a certain kind of discounts from us as well as those who refer others to us. Also, our customer service executives are well trained to handle all the inquiries and orders from our various clients here in Kentucky and also all around the United States of America. We believe that the above sustainability measures when deployed will be of immense benefit to our business. Check List / Milestone Business Name Availability Check: Completed Business Registration: Completed Opening of Corporate Bank Accounts: Completed Securing Point of Sales (POS) Machines: Completed Opening Mobile Money Accounts: Completed Opening Online Payment Platforms: Completed Application and Obtaining Tax Payer’s ID: In Progress Application for business license and permit: Completed Purchase of Insurance for the Business: Completed Conducting feasibility studies: Completed Generating capital from family members: Completed Applications for Loan from the bank: In Progress Writing of Business Plan: Completed Drafting of Employee’s Handbook: Completed Drafting of Contract Documents and other relevant Legal Documents: In Progress Design of The Company’s Logo: Completed Graphic Designs and Printing of Packaging Marketing / Promotional Materials: In Progress Recruitment of employees: In Progress Creating Official Website for the Company: In Progress Creating Awareness for the business both online and around the community: In Progress Health and Safety and Fire Safety Arrangement (License): Secured Opening party / launching party planning: In Progress Establishing business relationship with vendors – wholesale suppliers / merchants: In Progress Purchase of trucks: Completed Pharmaceutical Engineering Magazine Online Exclusives Special Reports Facilities & Equipment Information Systems Product Development Supply Chain White Papers iSpeak Blog Editorial Calendar Article of the Year Submit an Article Editorial Team Business Continuity Planning to Prevent Drug Shortages As noted in the ISPE Drug Shortages Prevention Plan, 1 business continuity planning is a powerful, methodology, essential for enabling an uninterrupted supply of critical medicines for patients in challenging manufacturing circumstances. This “30,000-foot view” article shares an executive summary of principles and best practices of business continuity planning to ensure continued pharmaceutical supply. 1 International Society for Pharmaceutical Engineering. “ISPE Drug Shortages Prevention Plan: A Holistic View for Root Cause to Prevention.” October 2014. https://ispe.org/DrugShortagesPreventionPlan While powerful, business continuity planning is not always leveraged optimally for preventing drug shortages because it can be difficult to initiate and maintain, particularly when future supply challenges may be unknown or unpredictable, and because it can require a significant investment of money, personnel, training, and other resources. However, over the lifespan of any company, unexpected challenges will inevitably surface. The COVID-19 pandemic is the most illustrative example of our times regarding how significant business continuity planning may be to ensuring uninterrupted supply of critical medicines, as the entire pharmaceutical industry has been challenged by both unprecedented demand and supply constraints globally. It is understandable how immediate operations necessary to maintain routine supply to the market may be prioritized over proactive measures, which may never be needed or needed in the way that was originally anticipated. Yet it remains essential that pharmaceutical industry leaders pursue strategic approaches for business continuity planning because drug shortages may devastatingly impact patients and their families, as shown in the recent ISPE Drug Shortages Webinar, which described one pediatric cancer patient’s challenges from multiple drug shortages. 2 In recent years, large-scale events have motivated governments, health authorities, and patients to focus on the reasons behind supply disruptions. While many root causes are being explored, some markets are prioritizing business continuity planning for the prevention of drug shortages and making these plans a requirement in certain cases. 3 , 4  Any procedures established to meet these new requirements should be developed with sufficient flexibility to accommodate appropriate evolution of business continuity planning because the risks of today may not be the risks of tomorrow. Approaches to Business Continuity Planning The guidance presented in this article is intended to assist pharmaceutical leaders in striking the right balance between critical patient needs and the business investment for drug shortage prevention measures. In general, the concepts described herein apply to all types of pharmaceutical products, including active pharmaceutical ingredients (APIs), finished drugs, biologics, vaccines, medical devices, and combination products. There are a number of excellent resources for business continuity planning. Notably, the ICH Guideline for Quality Risk Management Q9 5 serves as an important resource document for existing practices, standards, and guidelines within the pharmaceutical industry. As such, ICH Q9 concepts and terminology will be used throughout this overview. At the outset of pursuing robust business continuity planning for preventing drug shortages, it is important to recognize this is not a one-time event. Rather, the four primary activities in business continuity planning—establishing product priority, evaluating risk to supply, developing mitigation options and agility strategy, and implementing response plans—will need to be revisited and adjusted as the product portfolio and business dynamics change over time (Figure 1). Therefore, companies should develop programs to support an ongoing refresh of their business continuity plans. 2 International Society for Pharmaceutical Engineering. “Resolving and Avoiding Drug Shortages and the Health Crises They Create” (webinar). 1 September 2020. https://ispe.org/webinars/video/resolving-avoiding-drug-shortages-health-crises-they-create-webinar> 3 Garnier, Y. “The French System for Preventing and Managing Shortages.” BlueReg Pharma Consulting. 28 May 2020. https://blue-reg.com/the-french-system-for-preventing-and-managing-shortages 4 Covington & Burling LLP. “CARES Act Reforms Aim to Prevent Shortages of Critical Medical Products.” 5 April 2020. https://www.cov.com/-/media/files/corporate/publications/2020/04/cares-act-reforms-aim-to-prevent-shortages-of-critical-medical-products.pdf 5 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline: Quality Risk Management Q9, Current Step 4 Version.” November 2005. https://database.ich.org/sites/default/files/Q9%20Guideline.pdf Generally, the four stages of business continuity planning will proceed in the order shown in Figure 1; however, as patient needs develop or business or regulatory landscapes change, it may be appropriate to make targeted adjustments within any one of the four stages to ensure the best outcomes. In each of the four stages, a strong partnership between functional areas within a company will be required for success. The functional areas typically involved in these activities are as follows: Customer relations External business partnerships Manufacturing Medical affairs Procurement Regulatory affairs Sales and marketing Supply chain Technical/manufacturing operations Because many issues and decisions related to business continuity planning will be best addressed after input is considered from multiple functional areas, it is equally important to formally designate a business continuity planning team leader who will have the authority to exercise decisions on behalf of all. Figure 2 illustrates the key stages and decision points for business planning discussed in this article. Establishing Product Priority A foundational activity for business continuity planning is determining the priority of products. Not all products merit the same level of business continuity planning because the impact of supply disruptions is not equal for all products. Considering product priority becomes even more important when the resources required to develop business continuity plans may be constrained. The relative priority of each product will be more reliable if it has been determined by evaluating products individually, as well as across the portfolio of products for which the company is the marketing authorization holder (MAH). This is because there may be important connections between products, often business related, which can influence the priority of an individual product. Three perspectives primarily drive prioritization of products: therapeutic importance, regulatory requirements, and business significance. Because of the numerous perspectives that must be considered within these three areas when establishing the product priority, the evaluation of priority is best completed as a cross-functional activity and experts in the business areas listed previously should be consulted. Therapeutic Importance The medical significance of a product for patients is the most significant consideration when determining that product’s overall priority. There are several ways to differentiate the therapeutic importance of a product (Figure 3). Applying one therapeutic assessment globally is usually not sufficient because a product may have different therapeutic value across various markets. Additionally, within or across markets, each dosage form and strength within a product family may not always have the same medical priority. Sometimes, a specific dosage form and strength is developed to provide convenience to the health provider or patient and, as a result, its unavailability may not be as impactful as shortages of other dosage forms and strengths. Regulatory Requirements Health authorities (also known as national competent authorities) and health organizations, such as the World Health Organization (WHO), can influence product priority significantly through their definitions of what products may be critical, essential, or life-saving for patients in certain markets. They may also designate medically significant products through a set of criteria or through a list of products. For example, the WHO has long maintained an Essential Medicines List. 6 Additionally, governments may establish incentives to prioritize products manufactured in a certain market. Typically, health authorities have higher expectations for risk management and business continuity planning for products deemed to be more significant in their market(s). Currently, there is no harmonized definition across markets regarding what products are significant to the patients. 7 , 8 As a result, it is imperative that pharmaceutical companies have insight into the definitions or lists applicable for the markets where their products are sold, and which products may be assigned to a national stockpile. Notably, the priority may be dynamic in a market. For example, in a large-scale event, a product that is valuable for emergency use could rapidly become essential and in high demand. In addition to considering all regulations and governmental expectations when assessing the priority of a product in each market, it is important for companies to maintain constructive interactions with health authorities. 9  This will ensure that a company is able to develop a strategic approach to meet requirements across all markets and be poised to engage with the health authorities prior to or at the outset of any significant supply disruption or emergency. Early communication on drug supply challenges, preferably before supply disruptions occur, will maximize the assistance the health authorities may be able to provide to mitigate or prevent a drug shortage. Business Significance Business significance of a product should be assessed both from the perspective of the overall revenue position for the company as well as the market share of the product. If a product is essential for a company’s revenues, there may be no financial tolerance to have product supply unavailable for even a day. On the other end of the spectrum, a product might be sold in very low volume and manufactured only once or twice per year. Beyond failure-to-supply costs, which may be written into supply agreements, a supply gap for a low-volume product may have minimal patient impact or business significance. However, even an absence of a small-volume product can create significant challenges for patients who may rely on it, which could then generate business challenge for a company if the health care provider or patient reaction to the absence of product generates unfavorable publicity and impacts the overall reputation of the company. A market share analysis is an important activity to complete when determining business significance. It should include an analysis of how much market share the company holds for the product, as well as how interconnected the competing suppliers may be to the manufacturing nodes. Generally, if the market for a specific product is divided across at least three manufacturers, 10 a supply disruption from one manufacturer may not make a significant difference to the overall market. However, if the market share is divided unevenly and the manufacturer experiencing the supply disruption contributes significantly to the overall industry-wide inventory, the disruption may drive an industry-wide shortage and competitors may have insufficient capacity to increase manufacturing to address the supply gap. Additionally, a product may be a higher priority if any risks to supply would likely impact multiple suppliers (e.g., all companies use the same raw material supplier), and very quickly create an industry-wide gap. Lastly, connections between products, either within the portfolio of one company (i.e., one MAH holder) or connections with a partner company, may need to be considered when establishing the business significance for each product. One product may be interdependent with other products due to marketing, regulatory quality, or manufacturing supply requirements or strategies. Depending on the nature of the connection, a product that may otherwise be of lower priority may become more significant because interruption in its supply may impact other products the company markets or the company’s partnerships with other companies. Setting Business Continuity Planning Target Levels As noted earlier, the appropriate level of business continuity planning will vary by product. For the purposes of establishing a target level of business continuity planning, all of the perspectives described previously will contribute to the final priority categorization. Low-priority products do not typically merit rigorous business continuity planning activities, but the activities may be completed on a discretionary basis based on the company’s goals or preferences. For products that have priority from any of the three perspectives of therapeutic importance, regulatory requirements, or business significance, companies will need to apply an appropriate level of rigor to the business continuity planning activities, based on the perspectives driving the priority (Figure 4). 6 World Health Organization. “WHO Model Lists of Essential Medicines.” 2020. https://www.who.int/medicines/publications/essentialmedicines/en 7 ISPE Drug Shortages Initiative Core Team. “ISPE Offers Platforms to Progress Continuity of Supply of ‘Essential’ Medicines.” 11 September 2020. https://ispe.org/pharmaceutical-engineering/ispeak/ispe-offers-platforms-progress-continuity-supply-essential 8 Persaud, N., M. Jiang, R. Shaikh, et al. “Comparison of Essential Medicines Lists in 137 Countries.” Bulletin of the World Health Organization 97 (2019):394––404C. doi:10.2471/BLT.18.222448 9 Tomeo, D., K. Hirshfield, and D. L. Hustead. “Engage with Health Authorities to Mitigate & Prevent Drug Shortages.” Pharmaceutical Engineering 40, no. 4 (2020): 36–41. https://ispe.org/pharmaceutical-engineering/july-august-2020/engage-health-authorities-mitigate-prevent-drug 10 World Health Organization. “Medicines Shortages.” WHO Drug Information 20, no. 2 (2016): 180–185. https://www.who.int/medicines/publications/druginformation/WHO_DI_30-2_Medicines.pdf?ua=1 Assessing Risk to Supply Once the product priority is established for a product, the company can assess the risks to supply with a better gauge for the potential level of impact of any identified risks. The key learnings from establishing product priority should be considered during the risk assessment process. Table 1 shows typical areas to consider during a risk assessment for the purposes of preventing shortages. The areas listed are not exhaustive and may not be applicable to every product or company. Each company will need to determine what may best be included in their assessment and should address any company-specific issues or perspectives. Risk assessment activities may not need to be as comprehensive for low-priority products, particularly when any correlating supply disruption may have minimal patient impact. Table 1: Typical areas and topics for risk assessment of drug shortages. Area of Focus  Risk Assessment Considerations  Product  Supply Logistics Patients Environment The assessment of areas of potential risk should address the fundamental questions posed in ICH Q9: 5 What might go wrong? What is the probability it will go wrong? What are the consequences? An informal survey of ISPE membership has indicated that companies use a wide range of off-the-shelf and custom-designed risk assessment procedures, tools, and technology. ICH Q9 Annex I provides an overview of common tools for identifying what might go wrong and what is the probability it will go wrong. Table 2 1 , 5 , 9 – 17 lists other valuable guidance resources available to assist with the assessment of risk in pharmaceutical manufacturing. Table 2: Resources for business continuity planning to prevent drug shortages. Organization Resource Year ISPE How to Engage with Health Authorities to Mitigate and Prevent Drug Shortage 2020 FDA* Drug Shortages: Root Causes and Potential Solutions 2019 EMA Guidance on Detection and Notification of Shortages of Medicinal Products for Marketing Authorisation Holders (MAHs) in the Union (EEA) 2019 ISO ISO 14971:2019 Medical Devices—Application of Risk Management to Medical Devices 2019 WHO Medicines Shortages 2016 WHO Technical Consultation on Preventing and Managing Global Stock Outs of Medicines 2015 ISPE Drug Shortage Assessment and Prevention Tool 2015 ISPE Drug Shortage Prevention Plan 2014 PDA Risk-Based Approach for Prevention and Management of Drug Shortages 2014 ICH ICH Harmonised Tripartite Guideline: Pharmaceutical Quality System Q10 2008 ICH ICH Harmonised Tripartite Guideline: Quality Risk Management Q9 2005 *At the time of publication of this article, a new guidance from the FDA regarding risk management plans to mitigate potential for drug shortages was anticipated, but not yet available. Risk assessments generally evaluate risks to (a) the product, (b) business systems, and (c) operations, and assessments of these three areas may be completed either individually or as a combination activity. When business continuity planning is done for only one area (products, business systems, or operations), the preventive measures may fall woefully short because product supply, business systems, and operations can all be disrupted simultaneously, such as in large-scale events (e.g., hurricanes, earthquakes, pandemics). Beyond evaluating manufacturing reliability and quality maturity, business continuity planning to avoid drug shortages may benefit from integration with any governance, risk management, and compliance (GRC) or enterprise risk management (ERM) activities already in place for the company. For example, regarding risk to operations, the transformative nature of the COVID-19 pandemic may increase the importance of completing financial viability assessments of business partners, with consideration paid to not only primary business partners but also secondary and tertiary business partners. If a company does not have a formal GRC or ERM program, industry experts and software are available provide guidance suited to the needs of the organization. 18 , 19 , 20 Mitigation Options The outcome of assessing risk to supply should be a road map of the key risks for the products, business systems, and operations to drive the selection of an appropriate business continuity approach. A robust response plan should include both traditional mitigation options, such as redundancy of operations or increased inventory for safety stock, and agility strategy. Agility, as defined herein, is applied in the absence of an immediate back-up facility or inventory stockpile and should enable quick operational reactions to ensure resiliency for continued supply. It requires advanced, forward thinking and preparation to be successful. A well-designed agility strategy can be equally successful as redundancy; however, because agility strategy is by nature infrequently practiced, if it all, there may be some unexpected variation in the outcomes when activated. An appropriate blend of redundancy and agility will typically provide the best resiliency for continued supply. Figure 5 provides insight into the key considerations when selecting the best target on the business continuity planning options spectrum. 17 a b International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline: Pharmaceutical Quality System Q10, Current Step 4 Version.” 4 June 2008. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf 11 US Food and Drug Administration. “Drug Shortages: Root Causes and Potential Solutions.” Updated 21 February 2020. https://www.fda.gov/media/131130/download 12 European Medicines Agency. “Guidance on Detection and Notification of Shortages of Medicinal Products for Marketing Authorisation Holders (MAHs) in the Union (EEA).” July 2019. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-detection-notification-shortages-medicinal-products-marketing-authorisation-holders-mahs_en.pdf 13 International Organization for Standardization. “ISO 14971:2019 Medical Devices—Application of Risk Management To Medical Devices.” December 2019. https://www.iso.org/standard/72704.html 14 World Health Organization. “Technical Consultation on Preventing and Managing Global Stock Outs of Medicines.” 8–9 December 2015. https://www.who.int/medicines/areas/access/Medicines_Shortages.pdf?ua=1 15 International Society for Pharmaceutical Engineering. “ISPE Drug Shortage Assessment and Prevention Tool.” 2015. https://ispe.org/sites/default/files/initiatives/drug-shortages/drug-shortage-assessment-tool-watermarked-307240.pdf 16 Parenteral Drug Association. Risk-Based Approach for Prevention and Management of Drug Shortages. PDA Technical Report no. 68. Bethesda, MD: Parenteral Drug Association, 2014. 18 Consultancy.org. “Global Risk Consulting Market Nears $70 Billion, Top 30 Consultancy Firms.” 13 December 2018. https://www.consultancy.org/news/101/global-risk-consulting-market-nears-70-billion-top-30-consultancy-firms 19 Gartner Peer Insights. “Integrated Risk Management (IRM) Solutions.” Accessed 26 December 2020. https://www.gartner.com/reviews/market/integrated-risk-management 20 G2. “Best GRC Platforms.” 12 August 2020. https://www.g2.com/categories/grc-platforms Securing backup facilities or materials for pharmaceutical production or stockpiling inventory are longstanding redundancy options to ensure product supply. Although redundancy is well defined and generates expected results, it is costly due to necessary operational overhead. Unexpected complexity may also develop when a company maintains additional facilities, sources of supply, or inventory. Additionally, an adequate number of trained staff and practice runs for back-up operations are necessary to ensure a successful and timely transition to the redundant option, when needed. In some cases, limitations on the number of suppliers or raw material sources mean that redundant facilities or sources of supply are very difficult or impossible to achieve. Given the implementation challenges or significant investment required to achieve redundancy or stockpiling, they are not always the best options for the manufacturing of every product or every step of manufacture of an individual product. For example, redundancy or stockpiling may not be appropriate for products that are deemed low priority for business continuity planning or products that involve few supply chain risks. Quite often, the decision for the best approach will require input from the various business areas listed earlier (customer relations, external business partnerships, legal, manufacturing, and so on). Because options analysis can quickly become complex, tools such as a decision-matrix method (e.g., Pugh matrix) 21 , 22 may help to guide selection of the best business continuity planning approach. An important financial perspective to consider for business continuity plan decisions is that, as a general rule, it is better to decrease the level of bound capital along the supply chain from raw materials to API to bulk to the finished goods level because this may decrease the financial impact of the business continuity plan. Increasing inventory of raw materials, API, etc., at the earlier nodes of the supply chain will typically ensure lower, more efficient levels of finished product inventory. It is usually most cost-effective to have a second source for raw materials, excipients, and APIs and only stockpile the finished goods to the level required to meet the marketed forecast. Idle capacity cost should also be considered in the overall investment calculation during the establishment of a contingency plan. Once redundancy and stockpiling decisions are made, operational agility will need to be developed to offset remaining risk for holistic business continuity planning. Agility requires a company to establish practices and processes to ensure they can address issues when they have occurred. Excelling in agility will allow a manufacturer to quickly pivot operations to maintain supply, such as increasing production or using alternative operations or materials to maintain product supply. Six Sigma 23 methodology may be helpful in evaluating and establishing appropriate agility approaches. Key areas for agility strategy are supply chain, quality, strategic processes, business relationships, technology, regulatory, and metrics. The following are examples of how agility may be achieved in these areas. Advance thinking about potentially appropriate alternate suppliers (e.g., for raw materials, API, or finished product) can give a company a head start when faced with how to rapidly work with an alternate supplier that is not registered. Robust due diligence activities and well-maintained vendor qualification programs and supplier arrangements are recommended, as they may provide invaluable insights about timely and viable options amid an unexpected supply interruption. Companies that can quickly and completely understand the interconnectedness of a product and operations with other products and end markets have superior strategic options to redirect inventory to address market-specific supply disruptions. Diversification of suppliers may ensure continuous supply. There are signs that a shifting manufacturing footprint may be on the horizon, particularly due to the impact of COVID-19 on the pharma industry. 24 , 25 Quality failures are the root cause for a significant number of drug shortages; 11 , 26  therefore, it is particularly important to ensure a robust pharmaceutical quality system (PQS) 17  across the life cycle of a product. A mature PQS—particularly in the areas of change management, monitoring, nonconformance investigations, corrective and preventive actions, complaint handling, and knowledge management—should identify early any issues that may impact continuous pharmaceutical supply, and this allows companies to implement appropriate and timely corrective actions to either mitigate or prevent a drug shortage. Lessons learned from regulatory inspections should provide opportunities for continual quality improvement. When developing manufacturing operations, it may be advantageous to group products with similar excipients to facilitate quick manufacturing switch outs. Having the ability to quickly ramp up one set of products and ramp down others could help companies mitigate a potential shortage situation. Challenging the system or operational practices periodically, based on lessons learned or other company experiences, can proactively identify new risks. Developing strong relationships with suppliers and contract manufacturing organizations (CMOs) to understand issues early is invaluable in ensuring the best outcomes for potential or actual supply disruptions. Having the ability to quickly start manufacture of a product at a CMO through contracts, foundational qualification work, and training (often referred to as a warm start 26 ) is an agile version of redundancy. Companies may want to establish relationships with competitors, so they may partner during significant supply disruptions to temporarily provide patients with an alternate source of supply. It can be challenging to use new technologies (e.g., continuous manufacturing) or an alternate type of existing technology (as described in scale-up and post-approval changes [SUPAC] guidance 27 , 28 , 29 , 30 , 31 for existing products. However, completing foundational development work for new or alternate technology before shortage event occurs may give a company a shorter runway for restart and may help the company adjust to increased demand. A well-planned regulatory strategy for registration dossiers may be a powerful way to mitigate or prevent drug shortages. As an example, ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) 32  describes post-approval change management protocols (PACMPs) for registrations that may potentially alleviate post-approval change requirements. With the appropriate level of process and product understanding, PACMPs may be instrumental in ensuring continuous supply. Therefore, investing in upfront development and regulatory work for agility purposes can be foundational to success. Well-developed practices and procedures for engaging health authorities in advance of supply disruptions may help companies mitigate or prevent drug shortages because with early enough insight into an event that may disrupt drug supply, regulators may be able to provide pivotal assistance to help the company address the issue. Metrics to assess agility may or may not be needed and should be established as appropriate on a case--by-case basis. That said, traditional metrics are very valuable and will often help companies know when agility strategy may need to be employed. Traditional metrics closely linked to drug shortage identification and prevention are quality measures and demand forecasting. See the ISPE Drug Shortage Prevention Plan 1 for a more in-depth discussion of important metrics. Companies may want to establish a target timeline for transitioning to alternate supply options defined in business continuity plans. This may help companies better understand the overall impact of such transitions and whether predefined mitigation will be sufficient to address a supply disruption event. Implementing, Monitoring, and Refreshing Response Plans After the mitigation options and agility strategy are determined, the business continuity plan should be summarized and communicated across the company. Communication tools should include risk control documentation. Additionally, there may be a need to prioritize the implementation of the business continuity plans if multiple plans are established simultaneously. The completion of the business continuity plan and communication of it are certainly noteworthy milestones to celebrate, but they are not the last steps. As noted earlier, circumstances for product supply may change over time, and these changes may impact the outcome of any of the business continuity activities described in the plans. As a result, planning is not a one-time project. However, companies with larger portfolios of products or limited staff may find it unsustainable to routinely reevaluate product priority, supply risks, and the resulting product response plan for each product. Therefore, it is essential to establish a process for a periodic review of changes in circumstances that may impact the risk outlook for supply of one or more products and merit a change to the established response plan. Though this process may vary by company, it is important to develop an event-based trigger to prompt interim reviews. Some key triggers are presented in Figure 6. 21 American Society of Quality. “Quality Resources: Decision Matrix.” Accessed 26 December 2020. https://asq.org/quality-resources/decision-matrix 22 Bouza-Rodríguez, J. B., A. Comesaña-Campos, and A. Menéndez-Díaz. “A Graphical Method to Assist Quality Decisions Throughout the Product Development Process.” Quality Engineering 26, no. 4 (2014): 467–478. https://asq.org/quality-resources/articles/a-graphical-method-to-assist-quality-decisions-throughout-the-product-development-process?id=8a0f57c336cb484b9784d9b948e4f412 23 Shanley, A. “Reinventing Lean Six Sigma for the Pharmaceutical Industry.” Pharmaceutical Technology 41, no. 10 (2017). https://www.pharmtech.com/view/reinventing-lean-six-sigma-pharmaceutical-industry 24 PwC. “Beyond China: US Manufacturers Are Sizing Up New and Cost-Efficient Global Footprints.” July 2020. https://www.pwc.com/us/en/library/fit-for-growth/assets/ffg-industrial-supply-chain-footprint.pdf 25 Steinberg, G. “COVID-19: How to Forge a Supply Chain that Withstands Severe Shocks.” Ernst & Young Global Limited. 27 November 2020. https://www.ey.com/en_us/consulting/how-to-forge-a-supply-chain-that-withstands-severe-shocks 26 a b Pew Charitable Trusts and the International Society for Pharmaceutical Engineering. “Drug Shortages An Exploration of the Relationship between U.S. Market Forces and Sterile Injectable Pharmaceutical Products: Interviews with 10 Pharmaceutical Companies.” January 2017. https://www.pewtrusts.org/-/media/assets/2017/01/drug_shortages.pdf 27 U.S. Food and Drug Administration. “Guidance for Industry: Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.” November 1995. https://www.fda.gov/media/70949/download 28 U.S. Food and Drug Administration. “Guidance Document: SUPAC-IR: Questions and Answers about SUPAC-IR Guidance.” February 1997. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-ir-questions-and-answers-about-supac-ir-guidance 29 U.S. Food and Drug Administration. “Guidance for Industry: Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation.” May 1997. https://www.fda.gov/media/71141/download 30 U.S. Food and Drug Administration. “Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.” September 1997. https://www.fda.gov/media/70956/download 31 U.S. Food and Drug Administration. “SUPAC: Manufacturing Equipment Addendum: Guidance for Industry.” December 2014. https://www.fda.gov/media/85681/download 32 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Q12: Final Version.” 20 November 2019. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf Because changes in circumstances may occur in many areas of the business, convening a multifunctional business continuity task force for periodic reviews of potential changes may provide the best opportunity to identify where modifications to a response plan may be warranted. The functional areas listed earlier in the article should be considered when assigning team members to a business continuity task force. It is important to select key metrics such as demand forecast, supply metrics, capacity, and inspection results that can provide early warnings of potential issues, and develop a plan for how the business continuity task force will monitor these metrics. Additionally, insight into key changes for each area will be needed. Processes should be established in each of the functional areas for how to escalate changes that may have significance to the business continuity plans and are therefore important for the task force to review. The processes should leverage existing systems, such as the quality change control process, for maximum efficiency and effectiveness. After the periodic analysis is complete, a plan for refreshing impacted response plans should be developed. Additionally, the status of implementation of all business continuity plans and related updates should be monitored by the business continuity task force. Lastly, and very importantly, any use of established business continuity plans to address an unexpected supply disruption will present an opportunity for evaluating how well the plans worked and if any adjustments should be made. In the absence of actual events, the business continuity plans may also be challenged with announced or unannounced practice runs. The business continuity task force should lead efforts to execute or challenge the business continuity plans and to evaluate the resulting lessons learned. Health Authority Communications Health authority interactions and communications are an identified component in the quality risk management process in ICH Q9 and may occur at any point during the different stages of business continuity planning or execution. With respect to ensuring continuity of drug supply, it is important to recognize that regulations are in place to ensure the safety, efficacy, and quality of pharmaceutical products. However, it may be riskier for patients to go without a drug, due to supply disruptions, than to use a drug that does not meet all regulatory provisions. Sometimes, the issue driving the supply disruption will have little or no bearing on the safety, efficacy, or quality of the product, or the issue may be addressed in an innovative way that is not covered by the registered application. Therefore, it is important that MAHs consider all options to achieve responsible regulatory compliance that keeps the benefit/risk profile of the patient at the forefront, and interact candidly with health authorities to determine the most appropriate path forward during challenging circumstances. This article summarizes key stages and decision points for successful business continuity planning to mitigate and prevent drug shortages, and the foundational concepts described are aligned with ICH Q9 guideline, Quality Risk Management. 5 The approach was developed from across company experiences and has benefited from preliminary learnings from the COVID-19 pandemic. It will be reviewed and updated, if required, based on further learnings emerging from industry interactions and regulatory feedback. Each drug shortage event presents unique challenges and opportunities for improvement, and the events related to COVID-19 are no exception. One of the many outcomes of the COVID-19 pandemic has been that companies have needed to rely on business continuity planning to be more flexible and sharpen their focus on ways to ensure continuous supply of critical medicines. When we overcome these difficult times, it will be important to understand which business continuity measures worked well during this enormous, global event and which did not. There will also be an important opportunity to identify which manufacturing or business practices developed during the pandemic may be appropriate to implement routinely for greater effectiveness in the supply chain overall. Exciting new directions and enduring solutions for preventing and mitigating drug shortages may be achieved, and this constant evolution in the business continuity planning space should always be embraced. The ISPE Drug Shortages Team is a team of multidisciplinary experts who seek to assist ISPE membership, industry, and regulatory collaborations to reduce drug shortages globally through technology, quality, and manufacturing innovation and regulatory compliance. This team is actively monitoring developments related to drug shortages and is available to respond to any associated questions. We welcome input on best practices to support the continuity of supply and decision-making regarding actual or potential drug shortages. Larger versions of the figures in this article are available here: Business Continuity Planning to Prevent Drug Shortages figures Acknowledgment The ISPE Drug Shortage Initiative Team collectively developed the content for this article and special recognition is extended to the following contributors: James Canterbury, Principal, Ernst & Young LLP, Iselin, NJ Dawn Culp, BS, Hikma Pharmaceuticals USA, Inc., Berkeley Heights, NJ Nasir Egal, PhD, Sanofi, Washington, DC Erin R. Fox, PharmD, University of Utah Health, Salt Lake City, UT Jean Francois Duliere, Pharmaceutical Senior Expert and Consultant, Paris, France Emma Harrington, Moderna, Norwood, MA, Drishya Nair, MS, Ernst & Young US LLP, Iselin, NJ Terrance Ocheltree, PhD, RPh, Corium, Inc., Libertyville, IL Christopher J. Potter, CMC Pharmaceutical Consultant, Marlborough, UK Thomas Zimmer, PhD, ISPE Vice President, European Operations , Harxheim, GER 'Share on Twitter' About the Author Related Articles This article summarizes the key findings from the 7th Pharma 4.0™ Survey, conducted in 2023. It explores the demographics of the survey respondents, maturity levels of Pharma 4.0™ adoption, enabling technologies being leveraged, anticipated benefits, and challenges encountered. The regulation of drug shortage prevention has rapidly changed over the past several years due to large-scale, highly visible events, such as the COVID-19 pandemic, hurricanes, and geopolitical issues. Efforts to effectively address the complex and multifaceted issues contributing to drug shortages require close technical collaboration and clear communication between the pharmaceutical... On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and... Personal Finance Today's Paper Partner Content Web Stories Entertainment Social Viral Biocon inks deal with Tabuk Pharma to commercialize GLP -1 products in Middle East Biocon said that it has signed a licensing and supply agreement with Tabuk Pharmaceutical Manufacturing Company to commercialize its GLP-1 products for treating diabetes and chronic weight management, in select countries of the Middle East. Tabuk Pharmaceutical Manufacturing Company is a fully-owned subsidiary of Astra Industrial Group, a leading pharmaceutical company in the Middle East and North Africa (MENA) region. Click here to connect with us on WhatsApp Glucagon-like peptide-1 (GLP-1) are medications that help lower blood sugar levels and promote weight loss. They are physiological hormones that have multiple actions on glucose, mediated by the GLP-1 receptors released from gut enteroendocrine cells and control meal-related glycemic excursions through augmentation of insulin and inhibition of glucagon secretion. GLP-1 also inhibits gastric emptying and food intake actions, maximizing nutrient absorption while limiting weight gain. Under the terms of this agreement, Biocon will develop and manufacture the products and Tabuk Pharmaceuticals will hold the marketing authorization rights, and be responsible to register, import, and promote them in the region. More From This Section Volumes soar at Nuvama Wealth Management Ltd counter Bondada Engg hits the roof on securing work order worth Rs 468 cr Thangamayil Jewellery's board OKs to raise upto Rs 600 cr Nifty scale above 26,250; metal shares rally for 6th day Rites consortium emerges L-1 bidder for Delhi Metro Project The agreement also provides for a provision to expand to other glucagon-like peptide (GLP) products, as well as the option of a tech transfer that will enable localized manufacturing at a later stage. Siddharth Mittal, chief executive officer and managing director, Biocon, said: "I am pleased to expand our partnership with Tabuk Pharmaceuticals, which paves the way for our vertically integrated, complex GLP-1 formulations entry into Saudi Arabia and other countries in the region. The partnership is further validation of our concerted focus on GLPs and Peptides as future growth drivers." Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. The companys conosldidated net profit surged to Rs 659.7 crore in Q1 FY25 as compared with Rs 101.4 crore in Q1 FY24. Revenue from operations increased marginally year on year to Rs 3,432.9 crore in during the quarter. The scrip rose 0.35% to currently trade at Rs 373.80 on the BSE. 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Flow Like Electricity Sam Altman, OpenAI’s chief executive, is talking to the United Arab Emirates, Asian chipmakers and U.S. officials to expand the computing power needed to build artificial intelligence. Share full article By Cade Metz and Tripp Mickle Reporting from San Francisco Late last year, Sam Altman, the chief executive of OpenAI, started pitching an audacious plan that he hoped would create the computing power his company needed to build more powerful artificial intelligence. In meetings with investors in the United Arab Emirates, computer chip makers in Asia and officials in Washington, he proposed that they unite on a multitrillion-dollar effort to erect new computer chip factories and data centers across the globe, including in the Middle East. Though some participants and regulators balked at parts of the plan, the talks have continued and expanded into Europe and Canada. OpenAI’s blueprint for the world’s technology future, which was described to The New York Times by nine people close to the company’s discussions, would create countless data centers providing a global reservoir of computing power dedicated to building the next generation of A.I. As far-fetched as it may have seemed, Mr. Altman’s campaign showed how in just a few years he has become one of the world’s most influential tech executives, able in a span of weeks to gain an audience with Middle Eastern money, Asian manufacturing giants and top U.S. regulators. It was also a demonstration of the tech industry’s determination to accelerate the development of a technology it claims could be as transformative as the Industrial Revolution. When word leaked that Mr. Altman, 39, was looking for trillions of dollars, he was mocked for seeking investments equivalent to roughly a quarter of the annual economic output of the United States. Officials in Washington also expressed concerns that a U.S. company was trying to build vital technology in the Middle East. To build A.I. infrastructure in a number of countries, American companies would need approval from United States officials who oversee export controls. We are having trouble retrieving the article content. Please enable JavaScript in your browser settings. Thank you for your patience while we verify access. If you are in Reader mode please exit and  log into  your Times account, or  subscribe  for all of The Times. Thank you for your patience while we verify access. Already a subscriber?  Log in . Want all of The Times?  Subscribe . 204 IMAGES Pharmaceutical Company Business Plan Template for Startup Pharmaceutical Company Business Plan Template for Startup Pharmaceutical Company Business Plan Template for Startup Pharmaceutical Company Business Plan Template for Startup Pharmaceutical industry template design in A4 size. 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