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“I got a customer with a complaint screaming down the phone at me, wh

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

at do I do?”

Do not go on the offensive but listen to their problem

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

Examples of combination products may in

hen repeat it back so they know you fully have grasped the problem fr

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

m their angle on the matter. Thank them for bringing the situation t

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

your attention. You cannot fix what you do not understand.

In order

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

Combination pro

to be professional, to diffuse anger listen to them carefully. Much

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

nger and frustration stems from people feeling misunderstood, ignored

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

or not cared for.

This problem might be something you are not aware

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

f yet so be grateful to them for bringing the important problem to yo

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

ur attention. See this as monitoring feed back direct from your custo

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

er almost a form of market research.

Be diplomatic to the customer,

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

Following aspects would a

t is not a personal item they might be attacking but a business probl

dd to the challenges in developing combination products:

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

m that needs looking at, so be business like about the situation.

Th

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

e ideal solution and your ultimate goal is win win, it costs a lot of

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

money to gain a new customer so this is a golden opportunity to win

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

ack a regular customer for life by showing you care and acting profes

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

Professional from academic institutions, pharmaceutical industries, health care indust

ionally.

Avoid confrontation or negative responses, be flexible.

Lo

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

ok for benefits and similarities in your situations rather than focus

.

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

ng on your differences.

Deal with any confrontation straight away.

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

Companies that provide selfless information through particip

upplied by Amicable Business Coaching - "Your Success Is Our Business

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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