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As small business owners, we all have at least two things in common when it comes to our companies: Keeping other people’s ha

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

nds off our personal assets and paying the lowest possible taxes (this usually means having profits taxed on our individual t

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

Examples of combination products may in

x returns.) That’s what the S-corporation is all about. While the limited liability company (LLC) is quickly taking its plac

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

, S-corporation benefits still do outweigh LLC benefits for many companies. But how do you know it’s right for you? Let’s tak

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

a look.

What is an S-Corp Exactly?

An S-corporation is basically a regular corporation (or C corporation) that decides to

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

Combination pro

o with a special tax status. Forming an S-corporation lets you enjoy the limited liability of a regular corporate shareholder

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

while paying income taxes as if you were a sole proprietor or a partner. Unlike a regular corporation, the S-corp itself does

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

not pay any income tax. Here’s a closer look at some of the perks involved with forming this kind of business entity.

S-Cor

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

oration Benefits:

• Less Risk. An S-corp is said to have less risk from government audits as a corporation, as opposed to so

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

e proprietor or LLC.

• Minimal Liability. As mentioned earlier, this is one of the biggest S-corporation benefits – having l

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

mited personal liability for business debts.

• Flexibility. With an S-corp, owners can use corporate losses to offset income

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

Following aspects would a

from other states.

• Tax Benefits. You can save on employment taxes by taking distributions instead of salary. And with an S

dd to the challenges in developing combination products:

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

corporation, there is no double taxation threat because the corporation is not a separate taxable entity. (I should mention t

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

at a handful of states do tax an S-corp like a regular corporation. You can check with your state treasury department to see

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

if yours is one of them.)

What’s Next?

Now that we’ve answered the question, “What is an S-corp?” You should have a good id

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

a whether or not it’s right for your company.

If you’ve decided to give it a go, you can proceed with the filing of regular

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

Professional from academic institutions, pharmaceutical industries, health care indust

orporation paperwork with the state (since the articles of incorporation are the same for the S-corporation.) Then, after you

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

receive all the paperwork back from the state, go ahead and fill out the IRS form that’ll give you that special tax status we

.

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

talked about. Of course, if you don’t feel comfortable doing this alone, you can consult an attorney, accountant or an online

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

Companies that provide selfless information through particip

incorporation firm. For what should be a reasonable fee, they’ll be happy to help with paperwork and to answer your questions

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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Mexico is the best and largest market for beverages in the world and the best opportunity for US and European beverage companies to export their products.

Textile manufacturing is perhaps one of the oldest known industries in India. It was in existence since the beginning of civilization, although a crude methodology has been used then. The total contribution towards textiles manufacturing in our country is approximately 20% of country’s industrial production and is also treated as the backbone of economy. This contribution is about 1/3rd of the foreign exchange earned by the government.

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