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A business plan can be an useful document whether you are still in the planning stages or already have an existing business. You can use a business plan for three basic purposes: comm

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

unication, management, and planning.

Before you begin writing your business plan you should make a date in the future (perhaps annually) to review and update your business plan. A bu

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

iness plan is never complete as a business should be a dynamic entity that continues to grow and change as the marketplace and key partners change.

A business plan is a communication

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tool to attract investors, lenders, employees, and partners. The development of a comprehensive business plan shows whether or not a business has the potential to make a profit. It r

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

quires a realistic look at almost every phase of business and allows you to show that you have worked out all the problems and decided on potential alternatives before actually launch

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ng your business. Studying your business plan will help future investors, lenders, employees and partners determine whether they wish to become involved with your business.

As a mana

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

gement tool, the business plan helps you track, monitor and evaluate your progress toward short- and long-term goals. The business plan is a living document that you will modify as yo

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

gain knowledge and experience. By using your business plan to establish timelines and milestones, you can gauge your progress and compare your projections to actual accomplishments.

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

Updating your business plan can also be a time to plan and brainstorm future changes and growth.

As a planning tool, the business plan guides you through the various phases of your b

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

siness. A thoughtful plan will help identify roadblocks and obstacles so that you can avoid them and establish alternatives. Many business owners share their business plans with their

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

employees to foster a broader understanding of where the business is going.

Before you begin writing your business plan, consider four core questions:

1. What service or product doe

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s your business provide and what needs does it fill?
2. Who are the potential customers for your product or service and why will they purchase it from you?
3. How will you r

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ach your potential customers?
4. Where will you get the financial resources to start your business?

A business plan will include three main sections covering the business de

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tails, financial data, and supporting documents.

The business details will include a description of the business, marketing overview, description of competition, operating procedures

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

personnel, and business insurance.

Financial data will include loan applications, capital equipment and supply list, balance sheet, breakeven analysis, income projections (profit an

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

loss statements) including a three-year summary, and cash flow.

Supporting documents should include tax returns for the principals, personal financial statements, a copy of franchis

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

e contract if a franchise, lease or purchase agreements for physical space, licenses and other legal documents, resumes of all principals, and letters of intent from suppliers.

While

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

you can outsource the writing of your business plan it is not recommended. As the principal force behind your business you are the one with the answers so you should be the primary in

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

volved in writing the plan. There is support available, including workshops, computer programs and tutorials, and mentors. You should involve your financial partners (such as your acc

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

untant and bank) as well as legal representatives.

Writing a business plan can be a challenging task but it can also be very rewarding in terms of the future success of your business

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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