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If you have never heard of Outsourcing or maybe heard of it and never k

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

new what it is and what it stands for. Well today, I am going to give

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

Examples of combination products may in

you a simple definition about outsourcing. The definition of "Outsourc

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

ing" in a simple form is like a contractor contracting a sub-contractor

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

. One company hire another company specializing in a define task that

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

Combination pro

many time the hiring company can accomplish but it is more cost effecti

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

ve to hire another company to accomplish it. China and India are the m

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

st common countries that companies usually outsource to because of the

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

cost effectiveness. Other related terms to "Outsourcing" is offshore m

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

anufacturing usually means offshoring or overseas. Late 80's to the 90

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

's "Outsourcing" has became a popular term in the business and manageme

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

Following aspects would a

nt world nationwide due to the inflation rate in the U.S. Outsourcing

dd to the challenges in developing combination products:

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

offshore is very attractive and it is not an avenue you want to explore

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

without properly research the companies you are dealing with because i

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

could be a company worst nightmare. This is why there are companies o

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

ut there that specialize in this fascinating industry.

There have been

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

Professional from academic institutions, pharmaceutical industries, health care indust

research made regarding whether or not outsourcing offshore is healthy

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

for American companies. According to John McCarthy, Forrester Researc

.

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

h’s Group Director of Research, “This is going to be one of the biggest

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

Companies that provide selfless information through particip

macroeconomic shifts in the overall U.S. economy in the next 10 years.

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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