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When you go on to legally form your own business, you will in many cases be faced with a few options: registering

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

an llc, a corporation, a partnership or just be self employed. The option of forming an llc is the one discussed i

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

Examples of combination products may in

n this article, as it is probably the best one in many situations.

LLC stands for Limited Liability Company. That

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

means that the company is a separate legal entity from the person who founded it. The meaning is that the person

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

cannot be personally responsible for the losses the company accumulates (except for his personal investment in the

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

Combination pro

company). It also means that the company itself can be sued legally for matters that concern it's activity, and a

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

gain, the person who owns and/or controls the company is not responsible (with a few exceptions).

LLC's also enjo

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

y several tax benefits. The person who controls the LLC is required to pay tax only once on the LLC's profits. He

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

is than exempt from paying any personal tax on the profits he gains from his LLC company.

Other advantages LLC's

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

have are that there is less paperwork and hassle to operate an LLC in compared with an incorporation. There is no

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

need for board and annual meetings, less files and reports to submit to the authorities and regulatory bodies. Al

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

Following aspects would a

l this leads to the LLC being a very attractive alternative for small and medium sized business, as a form of inco

dd to the challenges in developing combination products:

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

rporation that has many benefits and few disadvantages.

Forming a limited liability company is a fast and easy pr

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

ocess. All you need to do is decide on a company name and location. You need to pay a fee and submit the papers to

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

the Secretary of State in the state where the LLC is to be registered. All US states permit registering an LLC, s

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

o you'll have no problem completing the process in your own state. Each LLC should have a Registered Agent with a

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

Professional from academic institutions, pharmaceutical industries, health care indust

street address in the state where the LLC was registered. The Secretary of State office will provide assistance to

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

anyone who wants to register an LLC, and the process will be done in a few days.

The choice of business structur

.

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

e and the incorporation of it are important. LLC is a great fit for many businesses, but not all of them. So, you'

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

Companies that provide selfless information through particip

ll probably be best to consult with a lawyer before deciding on an incorporation that is best suited to your needs

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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