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Due to the labor shortage currently in the United States of America i

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

t often makes sense to outsource certain services of your company. F

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

Examples of combination products may in

or instance let's take the transportation industry and in particular

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

and transportation companies such as limousines, taxicabs and shuttle

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

buses.

There are many needs of these companies such as vehicle wash

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

Combination pro

ng and preventative maintenance, such as oil changes and lube. It may

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

not make sense to have full time mechanics and a shop on the propert

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

y, as that gets very costly with all the over regulations from OSHA t

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

o EPA cradle to grave laws.

Yet if the company outsources such opera

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

tional needs they can most likely save money and remain more efficien

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

. Keeping costs low is desired to maintain a proper return on investm

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

Following aspects would a

ent and make a profit.

For many years our company, OilChangeGuys.com

dd to the challenges in developing combination products:

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

serviced these types of companies and was able to provide such servi

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

ces to them on a routine scheduled service preventative maintenance p

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

rogram.

We made money by saving these companies money and were able

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 lower costs for such fleet services due to the economies of scale p

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

Professional from academic institutions, pharmaceutical industries, health care indust

rovided by the transportation companies, as our mobile unites could c

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

hange the oil in 10-units at a time, while all the vehicles were in a

.

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

row. Outsourcing operational preventative maintenance needs makes a

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

Companies that provide selfless information through particip

lot of sense for a whole lot of reasons, so consider all this in 2006

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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