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If you decide you’d like to reduce your tax burden, protect your assets, simplify your company operations or enter into cross border busines

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

s transactions for example, and you’re interested in whether an offshore company structure could help with any or all of the above, chances

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

Examples of combination products may in

are it could.

There are many ways you can use an offshore company, many benefits you can derive from the use of one and many locations in w

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

hich you can set one up…so how can you decide whether such a structure is applicable to you and how on earth should you decide where to inco

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

porate an offshore company?

What to Use an Offshore Company For

You can use an offshore company if you want to trade internationall

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

Combination pro

y or invest offshore. You can use such a structure to buy and hold real estate at home and overseas or to own intellectual property. Addit

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

ionally you can use such a holding structure for asset protection purposes and for the specific protection of certain asset classes.

If you

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

have staff you need to relocate overseas you can use such a company to employ those staff to maximise any taxation advantages of their inter

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

national placement. For your overall taxation planning purposes such a structure can be significantly advantageous and finally, if you’re i

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

n the eBusiness world or are internet based there are certain significant potential advantages available to you through the use of a properl

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

structured and located offshore company.

Where to Incorporate an Offshore Company

There are hundreds of locations in the world tha

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

Following aspects would a

t are considered ‘offshore’ – i.e., low or no taxation jurisdictions – but not all of the nations are secure and not all of the jurisdiction

dd to the challenges in developing combination products:

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

s are legitimate therefore you have to be very careful when deciding where to incorporate an offshore company.

Some of the best locations i

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

n terms of superiority of regulation and the potential benefits they offer are the British Virgin Islands, Belize, Panama, Gibraltar, Nevis,

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

The Seychelles and even the British Channel Islands but to determine where best suits you please consider the following:-

The tax regime of

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

the jurisdiction

The overall political and economic stability of the nation

The superiority of communications and technology

The spoken

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

Professional from academic institutions, pharmaceutical industries, health care indust

language and language of business operation

The basis of the legal system

The jurisdiction’s commitment to protecting an individual’s conf

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

dentiality

The exchange controls in place

The offshore jurisdiction’s banking facilities

The costs of company incorporation and ongoing m

.

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

anagement

Finally, to determine whether an offshore company can benefit you or to get help in selecting the most secure and beneficial juri

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

Companies that provide selfless information through particip

sdiction it is always wise to take expert advice – after all, if you get it wrong you could lose out financially and in terms of time wasted

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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The most important question you must ask yourself before you start a marketing strategy or promotion.

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