Main Subject - Business

This bulletin is not about choosing a name for your new business, its not even about developing business plans and it certainly is not about choosing to be inco

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

rporated, a partnership or a sole trader. There are dozens of resources about that.

This is all about that giant step from surviving in business to success

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

Examples of combination products may in

in your chosen niche.

It is one thing getting a business up and running but doing it right or even finding out what is right, is easier to say than do. Startin

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

and running a small business is great I've been doing it for over twelve years but we all have the same problems, we know there is a better way of doing it but

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

we can't always afford a consultant.

So what I've been doing is putting together all the useful information I've collected over the years and compiling it into

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

Combination pro

easy read sections that can be used by almost any business in the land.

So lets have a look at customer satisfaction (or more correctly dissatisfaction)

Comp

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

aints
Complaints are good as it allows you to improve on the areas your customers want you to improve. It is still as true as ever that ‘the customer is a

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

ways right’ and in dealing with them, they do at the end of any discussion, need to feel that their grievance has been fully understood. Most of the time, if y

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

u are doing something wrong you will never know about it, as most people do not like to complain, they just try another supplier.

Handling complaints Give all

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

complaints top priority, the quicker they are dealt with the easier it will be to solve. Talk to them don’t avoid them, they are your friends and want to stay

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

s customers (although at times it may not seem that way).

If a customer says they have received 3 inch long screws instead of 4 inch screws accept it and send

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

Following aspects would a

y first class post the replacements with a sincere apology. If the complaint is more subjective listen carefully and find out just what the customer is expectin

dd to the challenges in developing combination products:

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

you to do. If their suggestion seems too expensive or time consuming, firstly agree that their suggestion is sound and then offer other solutions that may be a

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

cceptable.

Be considerate and understanding, if you cannot resolve it there and then promise to get back to them by a specific time or date and keep to it, eve

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

if only to say you are still working on it.

As I said I have put together these tools (for want of a better phrase). I've broken them down into 12 sections

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

hat roughly match the way most small businesses run themselves.

The idea being you can tackle whichever area you think is giving you the most problems at the m

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

Professional from academic institutions, pharmaceutical industries, health care indust

ment, then you can move onto the next one or you could read the whole lot through then work on the easiest, that way as soon as you see the improvements, it giv

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

es you and your staff encouragement to tackle the more difficult ones.

There are umpteen books about starting businesses but all seemed to concentrate on namin

.

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

the business whether you should be a limited company, the sole trader, or whatever. They leave out the hard bit and that's a bit I'm covering with these prog

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

Companies that provide selfless information through particip

ammes.

There is more like this on our web site, so to start getting the returns that your effort expects, just collect a free detailed report from our web site

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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