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The members of the offshore dedicated team work under the supervision and control of the customer, and can

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

often be available during the business hours, needed for the customer. That is, the team may work the same hours as the bu

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

Examples of combination products may in

siness or they can work at the time, when the customer’s business is not working, thus creating a 24-hour working environme

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

t for a firm. Offshore dedicated teams often supervise the business processes on behalf of the customer, which guarantees

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

superior productivity.

Offshore dedicated team providers usually offer their customers software develop

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

Combination pro

ent centers with the newest technologies, often with various cost-reduction plans during all the period of the project. Whe

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

n hiring an offshore dedicated team, the client often gets much more than just professional IT specialists. The problem of

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

keeping a professional IT team together becomes the problem of the offshore center, which again helps save costs. The offsh

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

re center also takes care of taxes, which gives further cost savings options. These advantages allow the clients to invest

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

their resources into other important activities, not spending extra time and money on managing the everyday and routine tas

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

s.

Nowadays, offshore centers can offer a great number of offshore dedicated teams, which specialize in s

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

Following aspects would a

everal knowledge fields. IT development, web technologies, analytics, front and back office operations, intellectual proper

dd to the challenges in developing combination products:

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

ty services, clinical research, legal research, business research, publishing services, real estate services, case study se

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

vices, call centers, human recourses, customer care are only some of them.

An offshore dedicated team cen

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

ter is to some extent an extension of the customer’s business office. The center aims at presenting the best skilled work f

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

rce, facilities, and benefits to their clients, making the necessary operations to protect all the rights of the customers.

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

Professional from academic institutions, pharmaceutical industries, health care indust

The offshore dedicated team also offers a co

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

st effective plan for those intending to cooperate on a permanent basis. In this case the team is constantly trained to for

.

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

the specific needs of a customer, which ensures perfect quality of the services rendered. Finding and selecting the right o

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

Companies that provide selfless information through particip

ffshore dedicated team may be a time-taking procedure; however the benefits received by the customer are usually worthwhile

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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