Main Subject - Business

Raising capital to start a new business may seem like a daunting task, but it need not be overwhelming if you follow a few basic business practices. If you have a viable idea that will net a return for your investors and prepare a compelling business plan

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

the chances are good that you can find investors to join you.

If you're thinking about getting outside or equity capital to help fund your business, there are some things you need to do first, that can make your business more attractive to investors. Foll

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

Examples of combination products may in

w these simple ideas, and you'll be well on your way to raising the money you need.

First, always talk to a qualified business attorney (not your family lawyer). There are a lot of laws pertaining to how equity capital can be raised from the public, and t

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

e laws change often. You need someone who understands not only these laws, but also how to make sure that any business contracts are written to protect you and your business, especially the fine print.

1. Taking your company public. Although security laws

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

in the U.S. have made it easier for companies to go public, and offer stock as a way to raise needed funds, this is still probably the most risky choice. It is usually not a recommended option for very new or very small companies. Because of the number of

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

Combination pro

legal issues involved, consulting with a knowledgeable attorney beforehand is vital. There is also a lot of stress involved in running a public company, and a considerable loss of autonomy and control. Before making this choice, be absolutely sure that thi

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

is the wisest course of action for your business.

2. Getting money from relatives. Yes, it can seem like begging, and it's a difficult thing to have to swallow your pride. Surprisingly, in a recent survey, almost 30% of entrepreneurs said that they raise

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

d all or part of the capital they needed through family members. If this is your choice, make sure that you have your attorney draw up a regular business contract. When approaching family members, talk to them about their investment the same way you would

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

ny other outside investor. Tell them about how much money they can make, not about how much you need their help. And make sure that you keep to your end of the agreement.

3. Using your savings or credit cards. This is the most common way for entrepreneurs

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

to raise needed business capital. Before choosing this method however, talk with your financial advisor. You want to look at the long-term consequences of using your savings, life insurance or credit cards, especially in the event that your business ventur

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

fails, or does not bring in the projected return on investment (ROI). If you do end up financing your project using credit cards, make sure that you shop around first, and find the card that will offer you the best rate and gives you the most "bang" for y

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

Following aspects would a

our buck.

4. Venture Capital and Angel Investors. Before even looking for venture capital, look at your company from an outsider's point of view. Ask yourself these questions: Does your company have a solid track record? (Most venture capitalists don't in

dd to the challenges in developing combination products:

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

est in start up companies). Does your company have the potential of becoming very large in the next five to seven years? (People don't invest in your company out of the goodness of their hearts. They're looking for a return on their investment -- the large

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

the better.) Does your company own a good percentage of its market, or does it stand to gain a large percentage in the next 12 to 18 months? (Contrary to popular belief, your company doesn't have to be involved in high tech to attract venture capital). If

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

you can answer yes to the above questions, your next step is to find a venture capital firm whose ideals and goals are in line with yours. Your next step should be to look at your "circle of influence" and see if you know someone who can give you a person

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

l introduction to someone at the venture capital firm. (People invest in people, not just companies.)

5. Potential or Current Employees. Surprisingly, one of the most common ways (especially for new companies) to raise equity capital, is by inviting your

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

Professional from academic institutions, pharmaceutical industries, health care indust

otential or current employees the opportunity to become investors. With this method, not only do you get a really committed workforce, but many equity employees are also willing to accept a below-market wage in the beginning (especially if you do the same)

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

. There are other benefits, but this choice is not without its pitfalls as well. Again, before going this route, talk to your business attorney, and put policies into place that plan for potential problems. For example, what do you do if an employee's work

.

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

becomes substandard? Or an employee quits and goes into competition with you after learning all of the company secrets? Putting a risk management plan into place and considering all contingencies is your best bet for this option.

No matter which choice yo

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

Companies that provide selfless information through particip

make in looking for equity capital, by planning ahead, doing your homework and following the advice of your attorney, you'll increase the probability of raising the money you need and making the relationship between you and your investors a profitable one

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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