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Typically you should not e-mail any proposal unless you have reviewed it with the p

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

rospect first. I know with today's technology it's easy to send proposals in this f

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

Examples of combination products may in

shion, however a proposal loses much of its value if we as sales people don't prese

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

nt the information in a convincing way. That being said, if you do review the propo

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

al with them over the phone or in person and then e-mail/hand over the proposal to

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

Combination pro

them typically you will be asking a trial close trying to get them to either object

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

to it or buy it. If they indicate that the proposal is fine but they need to "talk

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

with other decision makers" or need to "think about it" then ask them when will the

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

be making the final decision on the proposal. Call them back on that date. Also if

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

you do get the “I need to talk with other decision makers” try to speak with them

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

s well. You should never let another sell your product.

Now if you have not asked

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

Following aspects would a

the "when will a decision be made" question then the day after sending the proposal

dd to the challenges in developing combination products:

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

through e-mail, call the prospect to see if they got it, could open it, and ask th

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

m if they can review the proposal with you on the phone either now or at a later da

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

te. If they have already reviewed it and don't have any questions, make a point to

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

ighlight a few line items that you thought where important to them and try to engag

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

Professional from academic institutions, pharmaceutical industries, health care indust

e them in a conversation or set a time to talk with them. After this conversation a

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

k a trial close to get a decision or get the "Call back date" if they are not ready

.

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

or willing to decide at this time.

Technology is awesome but a sales professional

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

Companies that provide selfless information through particip

is still needed to build value in any proposal and to get a prospect to take action

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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