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Subcontracting, or outsourcing as it is known in the Business Process industry, is a

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

trend that is developing the world over. Rather than starting an entire setup, many c

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

Examples of combination products may in

ompanies prefer to let others who already have a dedicated set up to execute a specia

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

ized task. Most large companies subcontract their marketing communication and adverti

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

sing to specialized advertising agencies There are many advertising firms that are re

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

Combination pro

ady to accept the subcontracts, with each one offering its own field of expertise. To

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

ay, subcontracting to advertising agencies is not only easy, but also advised.

Adver

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

tising agencies also subcontract to each other. There are various segments in an ad a

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

gency, whose work can be subcontracted to other agencies. Take the case of an ad agen

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

y that deals with advertising in the print media. Such an agency would have limited i

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

dea about television or online advertising. However, to offer a client a comprehensiv

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

Following aspects would a

e range of services, they might be obliged to offer a bouquet of advertising services

dd to the challenges in developing combination products:

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

which could include, which might not be their areas of core competence. In such a sc

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

enario, the agency can subcontract the specialty of online advertising to an agency t

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

hat specializes in it. This not only helps the advertising agency to focus on their c

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

re competencies, but also helps them get the best results even in those segments wher

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

Professional from academic institutions, pharmaceutical industries, health care indust

e they do not have a presence.

With the proliferation of special subcontracting agen

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

cies, there are a lot of options that one can choose from, depending upon the require

.

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

ent of the client and the agency. Quite a lot of these agencies have their own online

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

Companies that provide selfless information through particip

presence. One can find subcontracting agencies across the U.S. or in one's own state

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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The Internet has undoubtedly conquered every aspect of the business arena. It is rare to find business offices without computers these days. Practically a hundred percent of the business offices in the United States own computers to process their business transactions. This holds true in other first world countries such as Japan, Western Europe and China. In a simplified concept, the face of the earth is basically connected to the worldwide web that makes business more profitable and accessible.

The 3 Ps — picture or preferred future, principles, and purpose — are critically important questions. Our answers to these three basic questions define the team and/or organizational culture we are trying to create.

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