Advice You - Business

James S., from Las Vegas, N.V. asks, “I am very interested in starting a business, but just don’t want to put any of m

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

y property up for collateral due to some legal issues I have with my X-wife. I have a fairly good credit rating. Is there

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

Examples of combination products may in

any way I could get an unsecured loan for my business start-up?”

Many people thinking about going into business ofte

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

think only of a bank for a business loan, and do not even consider all of the other options such as an unsecured loan. B

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

ut all loan options should be considered when you are deciding how to finance your business, and an unsecured loan is an

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

Combination pro

ption.

Advantages of an unsecured loan:

Less documentation required – therefore, less work for

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

you or your CPA or attorney.

Your property is not used for security.

Loan approval is usually quick.

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

Closing the loan is hassle free.

Disadvantages of an unsecured loan:

Since the risk

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

is higher to the lender there will be a higher interest rate to pay.

If you need a large loan for your business,

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

ou may not be able to find a lender provide a large amount unsecured. (The definition of large varies by lender, but gene

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

ally a loan over $100,000 to $200,000 is large.)

The repayment term will be considerably less than a secured loan

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

Following aspects would a

. If you have projected enough cash flow to handle the larger payments, this may not be a problem.Your

dd to the challenges in developing combination products:

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

bility to get an unsecured loan will depend on some or all of the following:

You will be required to hav

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

a fairly good credit score. The minimum score will vary by lender, but a minimum will usually be in the 700 range, plus

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

or minus about 50 points.

Generally you will still have to have a good business plan which shows probable busines

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

success.

Your ability to get the loan will go up if you are buying a proven business or franchise. If you are st

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

Professional from academic institutions, pharmaceutical industries, health care indust

rting the business from scratch, you will probably have to show substantial net worth, or some other proof of financial s

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

tability, to get the loan.There are many sources for an unsecured loan. Your business or

.

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

http://www.WeGetBiz.com">franchise consultant should be able to direct you to a number of sources they have been succ

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

Companies that provide selfless information through particip

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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