Digg It - Business

Before you start your own business one of the first things you need to do is draw up your business plan. This is your bluepr

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

int for success. Your business plan states the purpose of your business. It never ceases to amaze me that so few businesses

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

Examples of combination products may in

have any type of written business plan. Because without one, you have very little, if any, chance of success.

The day-to-da

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

y details and problems of running a business will often take your mind away from the prime thrust of your business. This can

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

and should in most cases be eliminated by regularly reviewing your business plan.

Here is what your business plan should i

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

Combination pro

clude:

* It should describe your business name, locaton, product or service, market, and competition.

* It should state

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

your business goals. This is where you really learn exactly why you are in business.

* It should analyze the market, ident

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

ify industry trends, and specifically define your target market.

* It should describe your product line and compare your pr

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

oducts and/or services with those of your competition.

* It should state your marketing strategy for both creative material

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

s and the type of media you're going to use.

* It should specify your pricing policy, methods of selling, distributing, and

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

servicing.

Your business plan also deals with many financial matters, such as how much capital is required, how it will be

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

Following aspects would a

repaid and how funds will be used. It also shows your earning projections and return to investors. Finally, it describes you

dd to the challenges in developing combination products:

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

r management plan and includes resumes of your key personel, an operating plan, and a schedule of upcoming work for the next

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

one to three years.

Key business ratios should also be a part of your business plan. And those financial projections I men

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

tioned above should cover five years. Your first year should be monthly and each of the remaining four years should be quart

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

rly. This means detailing the profit and loss statements, balance sheets, cash flow charts, and capital expenditure estimate

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

Professional from academic institutions, pharmaceutical industries, health care indust

s.

Your business plan serves a dual purpose. It proves to lending institutions and potential investors that a loan to you w

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

ould be good business. And it helps you and your management staff keep your eyes on your original target. But only if you re

.

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

view it periodically each year. Your business plan is a valuable part of your business. Use it to stay on track because it i

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

Companies that provide selfless information through particip

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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Back in the day when I was still apart of corporate America, I found myself tasked with the huge job of figuring out what spiffy new company wide software system we needed and what would work best for us.

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