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Are you finding yourself in a position saying to yourself, my goodness why are all of my cli

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

ent’s getting rich and I am still working my butt off doing the same thing every day? If you

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

Examples of combination products may in

are a web developer and are so good at what you do? Then why don’t you stop serving clients

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

? You are reading this and have just been struck by lightning because you haven’t thought of

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

this yet or maybe you have but you just haven’t put a solid plan together.

I have one ques

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

Combination pro

tion for you. “If you are so darn good at producing professional websites and making them su

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

ccessful, why haven’t you built an empire of your own?”

It’s simple. You never set a goal.

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

You must first have a goal; tell yourself “I am ready to be successful.”

Success can be def

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

ined in many different ways, the way you define success is the first step. If you define suc

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

cess by running a web development business and pleasing your clients and you make 15% of the

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

gross sale per job and it covers just enough to pay your utility and mortgage bill then tha

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

Following aspects would a

t’s it, you are successful and that’s all you will ever need.

Or if success for you is, run

dd to the challenges in developing combination products:

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

ning your own web development business, expanding to 30 employees by the end of the month, o

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

pening a call center to take all of the call’s pouring in for web development and there are

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

so many call’s to take you don’t think you will ever get to them all, then this can be 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

definition of success for you too.

First step is to define success

Second you will need to

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

Professional from academic institutions, pharmaceutical industries, health care indust

wake up and smell the coffer. Realize that you have been the one sitting across this table

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

you are at now and helping and watching all of your client’s get rich quick because you can.

.

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

Third, you will need to find something of your own to marketing, and develop for yourself

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

Companies that provide selfless information through particip

since you are so good at it.

Fourth, thank me for sending the lightning bolt to your addres

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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