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Can you imagine taking your money to a bank and not knowing whether they would

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

deposit it into the correct account? I imagine that you would trust them to d

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

Examples of combination products may in

o the right thing and keep your banking transactions straight. The same is tru

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

when a customer buys your goods and services; they trust that you will follow

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

-through with delivering on time at the right location as promised. They expec

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

Combination pro

t that you will deal with them in an honest and truthful way. Trust is easy to

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

build when you have not had any dealings with the person before, there is no h

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

istory and people tend to trust each other unless something happens to destroy

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

it. Once trust is gone, so is the business relationship and the business with

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

this customer. Sometimes we think of sales people as untrustworthy, that they

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

will tell us anything in order to get us to buy. Not only that when we do buy,

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

Following aspects would a

they cannot deliver on their promises. Your customer trusts you to give them

dd to the challenges in developing combination products:

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

hat they have ordered.

The three most important things when dealing with cust

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

omers is to be loyal, reliable and honest. If any one of these ingredients is

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

missing, the relationship is doomed for failure. The same is true when you for

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

a Power Team or create an Alliance. Even leads groups expect the same. All of

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

Professional from academic institutions, pharmaceutical industries, health care indust

these elements add up to integrity.

One of your business mottos should be to

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

deal with customers in an honest and reliable way. Without this, your busines

.

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

dealings will be less than adequate. It is true there are people who deal oth

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

Companies that provide selfless information through particip

erwise and they appear to be successful but they are not necessarily respected

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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