Advice You - Business

Software companies are required to produce lots of software products for their clients. These software produ

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

cts being used for giant organizations such as airlines, banks, financial institutions, big corporate houses

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

Examples of combination products may in

and various government bodies, where lots of data being stored and updated every day. IT (Information Techno

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

ogy) software companies in US, Canada and Europe who are taking up these projects require massive investment

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

in infrastructure as well as huge manpower to work on them.

This is competitive world and every industry wa

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

Combination pro

nts to be very competitive in every business. So is IT software industry. To cut the labor costs, IT softwar

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

companies are increasingly outsourcing their jobs to developing countries in Asia, Latin American, Africa a

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

d Middle East. Since “cost saving” is the prime objective of IT software firms, it is estimated nearly 50% o

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

IT software jobs being outsourced to developing nations..

Most of the jobs outsourced are creating softwar

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

e in .Net, Java/J2EE, database solutions, smartcard solution and wireless/mobile application developments. B

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

O (Business Process Outsourcing) are also helping their foreign clients in voice and non-voice solutions, cu

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

Following aspects would a

tomer care, data management and so on. Outsourcing firms hire well educated English speaking young staff, wh

dd to the challenges in developing combination products:

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

are energetic and willing to work in shifts. These outsourcing companies charge very economical hourly rate

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

s and most of them are working even less than $7/- per hour, which is much lower than standard hourly charge

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

in U.S.

India has taken the lead in IT outsourcing jobs. Its Bangalore city is now said to be Mecca of IT

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

ndustry. With favorable government policies and substantial investment in infrastructure are making India as

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

Professional from academic institutions, pharmaceutical industries, health care indust

the great attraction for IT software outsourcing jobs. By outsourcing their IT jobs to India, U.S., Canadian

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

and European companies will not only save labor costs but this will also help them to be more competitive,

.

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

oncentrate more on core competent areas and enjoy tax benefits. Once the IT software jobs are outsourced, co

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

Companies that provide selfless information through particip

panies can concentrate on marketing, advertising, launching of new products, finding new customers and so on

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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