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Due to the low unemployment figures many people cannot get all the work

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

done with the local available labor so they will outsource some of the t

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

Examples of combination products may in

sks to other companies. This makes sense for so many reasons, as the com

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

any can concentrate on what it is best at and outsource the rest. Tasks

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

uch as office cleaning, truck washing, landscaping and concrete cleaning

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

Combination pro

are all potential outsource jobs. But what happens when the company you

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

outsource too hires illegal immigrants or illegal aliens?

Well this cou

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 be a real problem and potentially cause big public relations problems.

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

If you will recall recently the Federal Bureau of Investigation raided s

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

veral Wal-Mart Stores and found illegal aliens cleaning the stores. Wal-

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

art did not hire them, but they did hire the contract cleaning company,

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

Following aspects would a

who hired them? Another interesting case was the United States Navy, whi

dd to the challenges in developing combination products:

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

h hired a corrosion control company and they hired illegal aliens to do

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

orrosion control inside a Nuclear Submarine? Do you see the problem?

If

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

you are a company that is in the public image you might wish to consider

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

who you are outsourcing too and what their policies are on hiring illega

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

Professional from academic institutions, pharmaceutical industries, health care indust

l aliens. A disgruntled competitor might use such a mistake to make head

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

ines and destroy your community hard earned credibility. This could and

.

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

ill in fact hurt your public image and good will and it should be consid

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

Companies that provide selfless information through particip

red in advance of making your outsourcing choices to third party vendors

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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