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If you’ve ever wanted to buy a business with “no money down”, and have heard someone

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

say it goes on all the time and that it’s possible, then I have some good news and

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

Examples of combination products may in

ome bad news.

The bad news first: No matter what anyone says, you can’t buy

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

a decent business with nothing down.

In the 50 plus years I’ve been in busine

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, buying businesses and teaching other people how to buy businesses, I’ve never see

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

Combination pro

it happen. I've never once run into a seller that will let you in with nothing do

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

wn. It just doesn’t exist.

But here’s the good news: Just because you can’t

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

buy a business with nothing down, if you find one that makes sense and it’s large en

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

ough, you can finance it 100%, without using even a penny of your own money or borro

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

ing a dime from your friends, family and relatives.

How can I say this?

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

Because there are, in fact, lots of ways to finance a business –- including banks,

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

Following aspects would a

government loans, joint ventures, suppliers, owner financing and, my personal favori

dd to the challenges in developing combination products:

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

e, investors. You can use one of these methods or combine them however you like. M

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

ost of these tactics are relatively fast, simple and clean...and a lot easier than y

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

u may think.

When I was still teaching about buying businesses in seminars ma

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

y years ago, people would often confuse 100% financing with nothing down. But they

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

Professional from academic institutions, pharmaceutical industries, health care indust

aren’t the same thing at all.

The next time someone says you can buy a decen

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

business -- one that's not a dog, a turn around or some kind of Mickey Mouse operat

.

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

ion that's sinking fast -- with nothing down, run away from them as fast as you can.

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

Companies that provide selfless information through particip

Because chances are they’re trying to sell you on an idea that simply doesn't exist

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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Have you experienced exceptional customer service? How did it make you feel? I do not know about you but it gives me a wonderful feeling somebody showing they really care. When I receive service as such, I try to let the person or manager know. In today's world it is rare that you receive comments of satisfaction, much less for superior service.

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