Advice You - Business

Not too long ago, most merchandise you purchase from any first world economy is made in China. And

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

this is a logical occurrence due to the availability of cheap labor China readily provides. This

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

Examples of combination products may in

same concept applies in outsourcing services to another country where there is an educated labor po

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

ol which is acceptably cheaper than the labor pool available in the source country.

A lot of peopl

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

are still against the idea of customer care as a service department being outsourced to countries

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

Combination pro

such as India or the Philippines. However, coming from the perspective of business stake-holders,

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 an attempt to establish an edge over their competition, they are left with no choice but to take

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

advantage of the expense cuts that outsourcing can easily bring. As long as the service provider

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

s able to provide quality service, there is no difference whether the service an end-user is receiv

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

ing comes from the same country or another continent.

As negative as the reputation of outsourcing

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

is in America or in Europe, this trend is bound to continue along the lines of the global village

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

Following aspects would a

framework. One of the biggest fears for people is the myth that outsourcing is funneling precious

dd to the challenges in developing combination products:

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

obs to another country. Current trends see these jobs being sent to third world economies. But a

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

misconception remains. Jobs outsourced are non-vital responsibilities. As tempting as the advantag

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

es of cutting costs are to businesses, they cannot afford to risk vital decision making processes t

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

o entities outside their corporate umbrella. This means that employees who were previously tasked

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

Professional from academic institutions, pharmaceutical industries, health care indust

ith non-vital tasks will now be available to do more critical job responsibilities. There will be

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

no void in the job market as the misconception suggests. Rather, cutting costs will equate to a mo

.

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

re lucrative business environment with an inevitable increase in buying power and other opportuniti

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

Companies that provide selfless information through particip

es (better opportunities) will open up for employees who previously held non-vital responsibilities

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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Advice You - Sentiments Against Outsourcing

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