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If you are buying real estate, you must have awareness about legal cont

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

racts.

We have come up with some of the information related to legal 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

ntracts. You must know the legal aspect of it too.

When you buy a real

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

estate, you enter into a legal and binding contract. Today, the legal c

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

ntracts are quite lengthy. Real estate agents are very efficient as the

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

Combination pro

know all aspects of these legal contracts very well. You should ask yo

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

r agent to hand over a copy of it.

Ideally, you should go through the

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

contract and try to understand it and you should consult your agent If

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

ou are unable to understand anything out of it. All the words written

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

n this should be very clear and chosen carefully. Ask your agent make

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

comparison among your house and neighboring houses.

Your agent should

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

Following aspects would a

pay heed to all aspects before making an intelligent offer. Before you

dd to the challenges in developing combination products:

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

agent is going to make an offer, you should try to know the seller’s m

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

tive if possible. You should know the reason why this house is being s

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

old. What has been the duration of this house in the market?

You shoul

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

be realistic with your offer. The things like transfer fees issues are

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

Professional from academic institutions, pharmaceutical industries, health care indust

handled by local customs. You should be very patient, realistic and ed

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

cated of the process involved in it. If you make an intelligent offer,

.

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

you should be getting one or two more offers.

In short you should you

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

Companies that provide selfless information through particip

hould know what you are buying and more importantly, how you are buying

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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