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When you need system integration, do you handle it yourself or pass it on to a specializ

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

ing firm? If you are one of the many that handle this process yourself, you may 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

rethink just why you do this and if it is the right choice for you. Many skilled indivi

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

uals even pass off the process to others simply because of the time and investment that

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

s needed. What do you do with your system integration needs?

Here are some things to q

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

Combination pro

estion about whether or not you should be handling these needs or looking for someone el

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

e to do it.

• Beyond everything else, knowledge is power. If you are not sure you can

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

handle the task in front of you, then finding someone that can is an easy reason to look

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

elsewhere. There are any number of companies that can provide knowledgeable service to

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

our needs.

• But, that is not all in the least. Consider your time investment. How muc

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

time will it take to allow you to handle all of the system integration that you need?

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

Following aspects would a

ot just the actual input but the time for planning, for installing, testing and configur

dd to the challenges in developing combination products:

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

ng? This all adds up to one costly time expense.

• You may be thinking that you can ju

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

t pass the task on to an employee. Let’s just assume he does know what he is doing. Th

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

is too is a large investment in time. Just think about the things he could be accomplis

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

ing here. Your time or his time, it makes no difference. You need high quality results

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

Professional from academic institutions, pharmaceutical industries, health care indust

in a good time frame.

• Also, consider the expense. You will be paying someone to hand

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

e the integration. You will be paying for the integration. And, you’ll likely be paying

.

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

highly when it doesn’t go as planned.

System integration is something that you can easi

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

Companies that provide selfless information through particip

y have a firm come in and do for less stress, less cost and fewer problems down the road

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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