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You may find that the preliminary research is all that you need to conduct becau

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

se you already know enough. The organization may be listed in the top one hundre

; 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 it is a "famous" name. Even large companies have their problems. I worked wi

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

h a large company that was a spin off of another well known name. It was spun of

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

to streamline the parent company. The spin-off has three years to prove that th

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

Combination pro

y were profitable and then they would be on their own to discover new markets. W

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

ile dealing with this new organization, I found that they had adopted old proces

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

ses that did not allow them to be efficient. Their products were sound but their

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

accounting and human resource departments were in something of a chaos.

Every t

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

me I needed to get something done, the red tape made it almost impossible. They

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

id not pay their bills on time and sometimes even lost invoices. The company was

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

Following aspects would a

in deep trouble and the share price plummeted rather rapidly. Fortunately, they

dd to the challenges in developing combination products:

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

ere being supported by the parent company and there was a guarantee for payment.

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

They just were not very efficient. I do not mind doing business with such a comp

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

any but I do like to know ahead of time of what I will be up against when it com

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

s to payment time.

If you want to offer solutions, learn about the company and

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

Professional from academic institutions, pharmaceutical industries, health care indust

ts competition. The best way is to read their press releases for clues on what p

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

ojects they are working on and with whom. Go to .

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

w.prweb.com"> www.PRWeb.com Only when you know what is happening in their m

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

Companies that provide selfless information through particip

rketplace will you be better able to understand their current position and needs

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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