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Outsourcing is the latest phenomena in today’s world

The 5 W’s of outso

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

urcing are:

Who can outsource?
What can be outsourced?
Why shoul

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

Examples of combination products may in

it be outsourced?

When do we have to outsource?

Where do we outsource?

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

li>

Virtually everyone can outsource be it a small, medium or big business house. A

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

ything related to web designing, web development, B2B, B2C to name a few functions that c

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

Combination pro

n be outsourced. While outsourcing, we generally get a competitive edge without investing

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

in infrastructure. It evolves as the best logical option when we tend to loose focus on

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

he main issues while getting tied down by the necessary minor business facts. Countries w

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

th a competitive advantage are the best outsourcing destinations.

The United States can

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

really benefit from outsourcing as they have more opportunities than the rest of the deve

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

oping and developed economies. The US economy is growing creating new jobs in its wake. A

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

Following aspects would a

cording to the ITAA, IT jobs grew in the 2003 and still continue to grow at a rate of 3%

dd to the challenges in developing combination products:

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

since 2004 and expected to grow at the same pace till 2008. Outsourcing offers substantia

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

gains to the US economy providing cheaper imports and stronger markets for exports. Besi

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

es offsetting the costs, lowers the inflationary rates, increases production as well as l

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

owers the interest rates. Corporate earnings and consumers have also benefited from offsh

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

Professional from academic institutions, pharmaceutical industries, health care indust

re global outsourcing.

Outsourcing helps to improve the overall work productivity, reduc

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

the operating costs, enhance the speed and quality of the services while establishing lo

.

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

ng term and strategic relationships with their new offshore business partners. United Sta

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

Companies that provide selfless information through particip

es of America is definitely benefiting form outsourcing. However every coin has two sides

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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