Main Subject - Business

When you are negotiating a contract, there will be guidelin

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

es that determine the work to be completed and the timeline

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

Examples of combination products may in

to be followed. These guidelines often do not go into a lot

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

of detail on how the work is to be accomplished. Go beyond

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

the Request for Proposal (RFP) and deliver more than they b

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

Combination pro

argained for to gain a great business relationship and a so

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

id client base. The RFP is generally the first step in obta

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

ining the business and an additional contract will be negot

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

ated for the actual delivery of the product or service. Whe

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 negotiating, you will need to make sure that you can deli

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

er exactly what is promised and that you are not over exten

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

Following aspects would a

ing yourself. On the other hand you need to make sure that

dd to the challenges in developing combination products:

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

you are not under promising so that you can over deliver.

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

se your common sense to determine what is feasible and what

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

is not. If you say you can do more for the same money then

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

make sure it is in the contract. This way the competition i

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

Professional from academic institutions, pharmaceutical industries, health care indust

s not likely to gain ground on you. Remember it is in the e

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

ecution of the contract where the business relationship is

.

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

made or broken. If you can do more for the same money, say

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

Companies that provide selfless information through particip

o. The customer will be extremely pleased with their choice

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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