Advice You - Business

Business grants are surrounded by many popular misconceptions and myths. This is an attempt to put the record straight, and give you the knowledge required to su

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

ccessfully apply for your share of the free money everyone is talking about.

Myth #1: Everyone can apply for a business grant. The reality is, that yes, you ca

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

Examples of combination products may in

apply, but chances are that your application will be rejected; unless… That’s where the proverbial Pandora box opens. There are so many rules, laws and regulat

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

ons governing business grants that only experienced professionals should attempt to tackle them… and hope for a win. Yes, there is a promise of help, given by t

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

e grants’ administrators. But, it is usually limited to the “across the reception counter” conversation with the receptionist at the worst, or with some overwork

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

Combination pro

d clerk from the back office, at the best. Consequently, the quality of this free information leaves lots to be desired, and unless your business idea looks very

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

promising, you have no chance to succeed. Realize, that business grants are a highly specialized field, and an amateurish attempt will end in a huge disappointm

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

nt, wasted time, and a possible loss of money paid to incompetent “do-it-yourself” helpers. Besides, it makes sense to identify the grant that meets your needs,

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

confirm your eligibility, before embarking on the arduous road of the application process. Your outlay for engaging a professional business grants consultant wil

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

be relatively small; some quote a sum of $80 - $150 for the initial consultation. Rest assured, it will be money well spent; and the first instalment of the t

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

tal fee that you will be charged, should you decide to enter the application process, to obtain a business grant.

Myth #2: Business grants’ monies are free. S

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

Following aspects would a

emingly, that’s the case. If you comply with all relevant regulations, provide timely reports as required by the grantor, you may count them as free. However, i

dd to the challenges in developing combination products:

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

’s easier said than done. In order to prevent grant funds being misappropriated, or simply used outside of the nominated area, an imposing array of rules and reg

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

lations governs the process of business grants use. Regardless whether the funds are coming from the state or federal governments, or from a non-profit charity,

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

the plethora of associated restrictions can make you regret accepting these free monies, in the first place. Unless… you’ve done your basic diligence, and realiz

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

what’s involved. Again, it’s best to leave the administrative role for an external specialist, who will assure full objectivity in assessing whether your busine

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

Professional from academic institutions, pharmaceutical industries, health care indust

s grant is used correctly. This should protect you from failing periodic audits run by the grant’s administrator, and expose yourself to heavy fines and possib

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

e legal challenges.

By now, you’re probably starting to wonder if you should bother with business grants… While there’s no straight forward answer, considering

.

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

just two factors will help you make a correct decision. Firstly, can my business expand without any external funding? Secondly, can I get (and afford) a bank loa

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

Companies that provide selfless information through particip

? If you’ve answered “yes” to either of those questions, you may consider staying away from so called “free” money. Leave it for those, who have no other option

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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