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The limited liability company is a popular business entity choice for small businesses. One reason is the lack of

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

formality, but that doesn’t mean you shouldn’t document certain decisions.

A limited liability company is a busin

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

Examples of combination products may in

ess entity that combines the liability protection of a corporation with the tax flexibility of a partnership. It i

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

specifically designed for use by small businesses. One of the design factors is the lack of formality. Unlike a c

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

orporation, the running of the corporation does not require significant documenting in the company records. That b

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

Combination pro

eing said, you should still go ahead and record certain decisions.

A corporation is required to have an annual me

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

ting and keep minutes of it. Most people assume that a limited liability company does not have to do so. This can

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

be a mistake. An LLC is the product of state law and states tend to pass different legislation. As a result, your

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

state may require you to have an annual meeting even though you are an LLC. Failure to do so could put the legitim

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

cy of your structure at risk.

Any business should make a record of important business decisions. This is true reg

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

ardless of the type of business entity you are using. Why? Well, it creates a paper trail regarding how business w

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

Following aspects would a

as handled and by whom. This paper trail can save your bacon later on if a dispute arises, particularly if an inve

dd to the challenges in developing combination products:

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

tor starts questioning decisions.

Documentation is also a huge issue where owners do business with the company. T

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

he LLC is supposed to be a separate business entity, unique and independent from the owners in question. That bein

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

g said, many small businesses often will do business with owners. For example, a business might rent space from on

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

of the investors. This brings up issues of conflict of interest, to wit, is the investor getting a windfall of mo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ney? By documenting the decision at the time it occurs and the concurrence of all owners with membership interest,

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

you can avoid disputes down the line.

Finally, documenting important decisions made by the managers of an LLC ju

.

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

t makes practical sense. Documenting them means the managers took the time to sit down and actually discuss the de

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

Companies that provide selfless information through particip

cisions being made. In a small business, taking the time to deal with such issues can often help avoid bad choices

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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