Main Subject - Business

What business is just an Idea? Have you thought about what a business is. It is a idea. Thi

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

s sounds strange but I believe that it is true. Hears how. Before you start a business 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

et the idea. Before you get staff to work in your business they get the idea. Before your c

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

ustomer buys something they get the idea.

So the long and the short of it business is an i

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

ea. And you sell ideas. Whether it is to buy a computer or a fan. The customer and you need

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

Combination pro

to have the idea that you can supply the fan and deliver the fan. Without the idea nothing

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

happens or will ever happen. In this respect whither our business is a good one or a bad on

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

e it all biased on our ideas and belief systems.

By changing your belief you change your i

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

ea. This can also change the energy around your business and around you. If you approach yo

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

ur business through thought, and look at the basic way your business runs, think about

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

The enthusiasm you have about your business

The energy of your employees and v

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

Following aspects would a

olunteers if an N/P Organisation.

The excitement of your clients.

The fun

dd to the challenges in developing combination products:

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

level in your business. Fun sells - Just watch tv.

How you sell your products.

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

What are your customers wanting. (It may not always be the best price)

Appro

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

ching your business with this attitude, do you think you could look at your systems, custom

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

ers and improve your business to make it more idea friendly, more customer based. This may

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

Professional from academic institutions, pharmaceutical industries, health care indust

ll seam airy fairy stuff. But the bottom line is that you are working in your business tryi

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

ng to sell something to a customer. We often we forget what we started to do, and get caugh

.

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

up in the work of it all, when much of it will take care of itself. I am not mentioning th

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

Companies that provide selfless information through particip

at a business is not hard work because it often is. But we need to work smarter, not harder

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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