Main Subject - Business

Every business works within the context of core beliefs. We have developed beliefs that define how we work with clients, lenders and investors. We c

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

onsider them to be guiding principles that, if applied, will improve the quality of your business plan as well as the quality of your relationships

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

Examples of combination products may in

ith others. We share them with you in this article in the hope that you will find these beliefs worthy of adopting in your business as well.

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

/>Belief 1: Every business needs a written, organized business plan.

Every business, regardless of size, has goals and plan

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

for where it will be in the future. These goals and plans are often just in someone's head. The brain is a slippery place! If those goals and plans

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

Combination pro

are not written down, chances are they will be forgotten or altered on the fly without concern for the consequences. The discipline of preparing and

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

reviewing written plans often makes the difference between failure and success.Belief 2: A business plan must convey the understandi

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

g of the entrepreneur.

If you do not understand what you are planning, how can a lender or investor feel confident in your mana

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

ement ability? On the other hand, even if you understand your plans but can't convey that understanding to the funder, the perception is the same.

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

lockquote>Belief 3: A business plan is a resume of your financial skills.

Your business plan is a window through which inves

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

ors or lenders look at you and judge your financial skills. If your business plan looks like you have spent money unwisely in preparing your busines

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

Following aspects would a

s plan, they figure you will spend the investment funds unwisely. Likewise, if your business plan shows you don't have the skills to properly projec

dd to the challenges in developing combination products:

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

finances, they will not have confidence in your ability to control finances.Belief 4: Business plans are "owned" by those who make

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

hem.

We have found that for our clients to consider the business plan to be theirs they have to be deeply involved in its prepa

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

ation. Don't "invent" numbers for your business plan. Work to make sure the projections are yours and that you can confidently stand behind them.

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

ockquote>Belief 5: Projections are future budgets.

You should consider the projections for at least the next year to be your

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

Professional from academic institutions, pharmaceutical industries, health care indust

budget. Furthermore, you can't create effective budgets without projecting the next few years beyond them. Budgets must be prepared in the context o

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

future strategic and tactical plans.Belief 6: Projecting is not guessing.

Some people say you can make numbers

.

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

do anything. Understand this: planning is not a game. Business plans are just that ... planned actions and directions for the future. Make sure your

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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