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Choosing your business structure is just as important - if not more important - than marketing. You should consult with your accountant or your attorney in forming your business. T

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

he process in setting up your company is as follows; these are just the key points that need to be done, but not necessarily in the exact order listed.

First, you need to come up

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

Examples of combination products may in

ith a company name and ascertain if the URL is available for that website. If the URL is available for that name, the next step is to register that name with the Secretary of State

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

in the state that you reside in. At this point, there are two options: One is to consult with your accountant or CPA to decide if you should be a sole proprietor, partnership, limi

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

ed liability corporation or a Corporation. At the very least, reserve the name with your Secretary of State for a minimal fee while you decide what business entity you should be.

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

Combination pro

ere are the four types of business structures and a brief explanation of each:

1. Sole Proprietor - A Sole Proprietorship is one individual or married couple in business alone. So

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

e proprietorships are the most common form of business structure. This type of business is simple to form and operate, and may enjoy greater flexibility of management, less legal r

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

gulation, and fewer taxes. However, the business owner is personally liable for all debts incurred by the business.

2. Partnership - A General Partnership is composed of two or mo

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

e persons (usually not a married couple) who agree to contribute money, labor, and/or skills to a business. Each partner shares the profits, losses and management of the 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

nd each partner is personally and equally liable for debts of the partnership. Formal terms of the partnership are usually contained in a written partnership agreement.

3. Limited

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

Liability Corporation - A Limited Liability Company (LLC) is composed of one or more individuals or entities through a special written agreement. The agreement includes: provisions

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

Following aspects would a

for management, ability to assign interests and distribution of profits and losses. Limited liability companies are permitted to engage in any lawful, for-profit business or activi

dd to the challenges in developing combination products:

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

y other than banking or insurance. LLC’s cannot have more than 35 shareholders.

4. Corporation - A Corporation is a more complex business structure. As a chartered legal entity, a

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

corporation has certain rights, privileges and liabilities beyond those of an individual. Doing business as a corporation may yield tax or financial benefits, but these can be offs

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

t by other considerations, such as increased licensing fees or decreased personal control. Corporations may be formed for profit or nonprofit purposes.

As you can see, each entity

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

is somewhat different. In my opinion, I would either be a limited liability corporation or Corporation. There is a little bit more record keeping involved for a corporation, but is

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

Professional from academic institutions, pharmaceutical industries, health care indust

by far, well worth the time and effort that you expend. I attended to a financial seminar about 15 years ago and I learned that if I could take advantage of every deduction there w

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

s as, just a regular working person, I might only be eligible for 70 different deductions. If I owned a home there were a little over a hundred deductions. If I was in business fo

.

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

myself there were close to 200 available deductions. Here is where things changed: if I were a corporation, there were well over 300 deductions!

So, the moral of the story is th

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

Companies that provide selfless information through particip

s; if you can be a corporation, be a corporation, BUT you absolutely must talk to your accountant or attorney before you make a determination of which business entity you should be

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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