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Well, you got the bid in on time, possibly by dint of having your bid team, including word-processors and

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

print-room staff, working all night. You now have a few weeks in which to have a short post-mortem, ensur

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

Examples of combination products may in

e that all the in-house copies of the bid paperwork are safe and to return to your normal job managing the

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

projects that the company is already working on.

You will be aware of your customer's stated adjudication

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

period which may be anything from a couple of weeks to several months, or even years, depending on the co

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

Combination pro

mplexity of the bid. The customer will have a review team in place and they will, almost certainly, be co

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

piling a list of questions about your bid and those of your competitors.

You should have a procedure in p

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

lace for handling these questions. They should come from one designated member of your customer's team to

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

one designated member of your team. That person should record each question as it comes in, the name of

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

he person to whom it has been sent for answering, the answer and the date on which the answer was returned

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

to the customer. In this way, all questions will be answered in a timely fashion and they won't have the

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

Following aspects would a

opportunity to get lost between members of the team.

When all the questions have been answered in writin

dd to the challenges in developing combination products:

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

, the customer may want a face to face meeting with your team in order to have you clarify your answers to

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

his questions or he may give each competing company the opportunity to give a presentation with final cla

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

rifications of their technical solution and other matters. You must be prepared for this.

If the custome

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

want a presentation, it will need to be slick. Don't have too many people presenting and make sure they

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

Professional from academic institutions, pharmaceutical industries, health care indust

know what they're talking about. Have rehearsals in front of senior management and be prepared to answer

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

more questions.

If possible take a laptop computer with a Powerpoint presentation ready installed. Be su

.

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

e to take a backup disk as well as paper copies of your presentation, just in case of a technology failure

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

Companies that provide selfless information through particip

of some sort. In this way, you will have done everything possible to make sure that you win this project

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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