Advice You - Business

Do not pay for any help to obtain a grant to start a small business.

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

Grants do not exist for small businesses UNLESS the small business

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

Examples of combination products may in

wner wants it to be a non-profit and are willing to be audited and g

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

ive that money to others. [Which goes against the purpose 99% of the

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

time for opening a small business.] I have read hundreds of ads from

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

Combination pro

grant directory publishers and they constantly State "get free gran

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

s [redundant since a grant is a free thing in the first place].

The

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

IRS allows, under very limited conditions, a person to set up a non

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

profit organization to service, most often, educational services for

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

displaced adults and For home makers and such services.

But for th

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

se who have a good idea for a small business and seek government gra

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

Following aspects would a

nts To fund their business, same your grant directory money. OFFER t

dd to the challenges in developing combination products:

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

pay no one to Get you a grant because these grants are not for prof

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

it seeking businesses.

I only have 38 yrs advising small businesses

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

owners and owners to be about getting their Business started and whi

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

le there are dozens of ways of getting funds, getting a grant Is NOT

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

Professional from academic institutions, pharmaceutical industries, health care indust

among them.

When you visit your favorite library, seek ways to buy

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

a business using leverage and also seek ways to start on a "shoe str

.

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

ng" budget [selling receivables is the #1 way] but do not seek free

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

Companies that provide selfless information through particip

money, it is a waste of your valuable time.

RE broker and biz consu

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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Advice You - NO Grants for Profit Seeking Start-up Businesses [Only for Non Profits]

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