Useful Advices - Business

STOP! Before you take the first step in financing your business be sure that it is the bu

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

siness or property you definitely want to buy!

The following checklist of requirements w

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

Examples of combination products may in

ill help you get a quick approval for your application, usually within one or two weeks.

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

With a good business finance company or broker you can often get an approval within 24 ho

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

rs over the phone. Banks may take longer, but be sure of this - if you prepare before you

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

Combination pro

jump in you should have that answer in very little time.

(1) Fill out your application

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

form truthfully with all the information requested. Ask the broker to assist you if neces

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

ary

(2) Have a photocopy of your drivers license for all applicants on the loan

(3) Hav

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

e an appraisal of your home or business so you have some idea what its worth. Don't over

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

value your property because financiers depend on a close estimate to finance you

(4) Hav

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

your current payslips ready or an accountant's letter on your gross and net wages

(5) H

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

Following aspects would a

ave the financials ready to produce to the financiers for the business you are buying or

dd to the challenges in developing combination products:

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

the business you now own

(6) A copy of your home insurance papers

(7) A copy of your ex

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

isting home loan history if this is a refinance

(8) If you are financing to purchase a n

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

w business apply for an ABN number. Your financier will ask for this also

(9) References

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

from your current or last employer, or if you are self employed a personal reference fro

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

Professional from academic institutions, pharmaceutical industries, health care indust

m a business person or institution

(10) If you are one of the many people in a hurry to

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

inance and you have all the above ready to go you will help your financier to get you the

.

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

answers you want as quickly as possible. It's really up to you to speed the application.

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

Companies that provide selfless information through particip

Don't be afraid to be in constant contact with your financier until you have that answer

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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