Subjects - Business

While Outsourcing stands for giving out a part or certain parts of your business operations to a regional or local distinct business enti

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

ty, offshore outsourcing implies delegation of the selected business operations to an offshore location outside the country.

The two con

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

Examples of combination products may in

epts share some advantages and differ on others. The common benefits of outsourcing and offshore outsourcing include doing away with the

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

urden of mundane business operations that can be easily and skillfully handled at an off-site location, generally for a lesser budget. Ou

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

sourcing is a brilliant idea to relieve the business entity from vain exertion and instead pay better attention to ones specialized servi

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

Combination pro

ces areas or may be provide more agile customer care. Also, outsourcing excuses the enterprise from the substantial set up costs, viz. th

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

cost of work space, manpower, stationery, systems and other miscellaneous expenses that would otherwise incur, if the jobs are not outso

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

rced.

While local outsourcing manages just a couple, offshore outsourcing comes with a whole baggage of advantages. The highlights of of

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

shore outsourcing remain the niche economies available at the offshore location, including exceptional professional talent for considerab

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

ly lower costs. In fact, inspired by the dynamism of offshore outsourcing model in India, not less than 40% of the Fortune 500 companies

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

re already taking advantage of it, including big names like MicroSoft, Motorola, Oracle, GE and Lucent.

Economies of scale is another ci

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

Following aspects would a

able advantage from Offshore outsourcing, as offshore destinations generally conduct themselves as specialized ventures that also take up

dd to the challenges in developing combination products:

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

similar jobs from other companies across the globe. As statistics has it, offshore outsourcing can bring down the costs for you from 50%

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

to 30%, subject to onsite and offshore resources.

Offshore outsourcing also allows you to make a careful choice as regards the standard

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

imeframe on offer, so as to render the effective working hours almost round the clock. For example, IST and EST are complimentary in natu

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

e with around nine and a half hour difference. This in turn, considerably shrinks delivery time for US-based companies translating into a

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

Professional from academic institutions, pharmaceutical industries, health care indust

hievement of business targets well within budget and sped up job schedule.

Moreover, offshore outsourcing can span across wholesome back

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

end business operations; the most prominent of all being IT and IT enabled services (ITES) with a whopping 28% of the entire share. As pe

.

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

reliable reports, majority of IT based outsourcing contracts are already moving to India, in spite of competitive rates offered by China

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

Companies that provide selfless information through particip

and Russia. India offers wider talent and more purchasing power for US dollar, in turn saving billions of dollars for its US counterparts

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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