Main Subject - Business

Being your own boss and owning your own business can

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

be a lot of fun. For some they consider it part of th

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

Examples of combination products may in

ir American Dream. Many people decide to be their own

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

boss as solo-professionals and this makes sense, as y

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

u have no employees to deal with and if you need help

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

Combination pro

you can contract with others in the industry and work

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

on Team Projects.

If you are a solo professional the

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

you have many opportunities to succeed, call your ow

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

shots and fly by the seat of your pants; dead reckon

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

ng if you will. Of course with this tremendous opport

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

nity there is also the ultimate risk; you could fail

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

Following aspects would a

nd make mistakes in business and if you reckon wrong

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 dead, as they say. Meaning you could lose mone

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

and go out of business.

However there is a certain

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

mount of thrill in owning and running your own solo p

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

ofessional business and making decisions on the fly,

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

Professional from academic institutions, pharmaceutical industries, health care indust

hoosing your clients and which jobs you take. It is f

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

n to be creative and help other business succeed too

.

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

nd some of the projects you will get to work on are t

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

Companies that provide selfless information through particip

uly exciting indeed. Please consider all this in 2006

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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Main Subject - Solo Professionals and Dead Reckoning Discussed

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