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I am often asked the same two questions. Do I need a business plan? What should I include in my business plan? I am going to answer these questions when writ

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

ing this article.

Do I require a business plan?

For most businesses the answer to this question would be yes. For the majority of new businesses and ones w

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

Examples of combination products may in

hich require investment by way of a loan or a business partner, a business plan is a must. Any potential investor will want to see for example, your future g

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

owth projections before they commit to invest.

This is the type of business which does not require a business plan:

A business which is happy to stay as it

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

is and which has no plans to expand.

A business which never has a need to take out a loan.

A business which is a one man band and is self-sufficient, with

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

Combination pro

ut the need of any outside help.

This type of business is rare. Most businesses therefore will require a business plan.

It is one thing being aware of your

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

need to formulate a business plan, the problem is most people have no idea of how to go about creating one.

The business plan will aim to show its readers

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

ll about your aims for your business and how you are going to reach these targets. You need to have a strategy firmly in place before even attempting to writ

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

e the plan. You should know the direction you are going to take, the investments you are going to make in staff, equipment and machinery. You need to have bu

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

iness goals and an idea of when each target is likely to be met.

In most cases a business plan is used to try to attract people to invest into your idea and

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

business. It is your sales copy in effect and therefore if you create a professional, well laid out and strong business plan, people are more likely to take

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

Following aspects would a

you seriously and to invest.

On the other hand if it is rushed, poorly written and basically a weak business plan, you are unlikely to receive the backing

dd to the challenges in developing combination products:

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

ou are looking for.

What should be included in my business plan?

People who read your business plan will not only want to know about the business itself, t

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

hey will also want to know about you. Give them a brief summary of your history and what you have achieved in the past. Write down all of your ideas and real

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

y sell the positive side of your character to them. The fact that you are really hard working and that you thrive under pressure. You love a challenge and ca

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

n not only work well as part of a team but also on your own.

Describe the market place that your business is a part of, the competition and also the opportu

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

Professional from academic institutions, pharmaceutical industries, health care indust

ities for growth in that market.

Give them financial figures including running costs, projected earnings, projected growth forecasts and also any financial

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

history the business might have had.

Show them that you are flexible in that you have a plan B if plan A does not come to fruition.

Sell them your ideas by

.

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

telling them why you are setting up the business for example, and where you dream it will be in five years time.

Include a mission statement explaining what

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

Companies that provide selfless information through particip

you are attempting to achieve with your business.

I hope this information has helped give you an idea of how to write a successful business plan. Good luck

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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