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You must be able to define the ultimate goals and find the holes before you can lo

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

ok for team members to fill the void. Without this definition of where you want to

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

Examples of combination products may in

go and what additional services you want to provide, there is not point in adding

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

Power Team members. Establishing the ground rules first and then seeking "partners

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

" is the best route to take. One of the biggest questions that come to mind is whe

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

Combination pro

re to look for your team members. I have always found team members through looking

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

at my existing clients, people in organizations and leads groups that I am involve

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

d with. I never advertise for a team member, they are always referred to me by som

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

eone I know.

Once you find a potential team member, you will need to d

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

a background check with past customers and also their financial status. This does

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

not mean they have to be making lots of money; it simply means that you should ch

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

Following aspects would a

eck their credit rating. A healthy credit rating means that they are likely to han

dd to the challenges in developing combination products:

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

le their money well and you will not be left hanging by your fingers. I know a con

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

sultant that checks credit scores for everyone he does business with and he has tu

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

rned down contracts on this basis.

When you are adding a member to your

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

power team, you are actually creating a partnership with that person. Each person

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

Professional from academic institutions, pharmaceutical industries, health care indust

you interview will not only share some of your views but they will also provide yo

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

u with differences in opinion. Although I do value the differences, it is importan

.

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

to find out if they will cause a problem for you in the future. All I am really s

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

Companies that provide selfless information through particip

aying is that you should make your choices carefully and do not give away the farm

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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