Cases - Business

Applying for a Business visa is a major undertaking especially if you are thinking of relocating your business in Canada. One of the main processes to start the ball rolling is to be able to prove that the funds you have av

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

ailable are not the proceeds of crime. Any applications have to be made from the country of residence of the applicant.

People who are experienced in business matters or have sufficient funds for investment could qualify f

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

Examples of combination products may in

or a Business Visa. They are expected to contribute to the development of the Canadian economy either by investing in or starting a business in Canada. There are three different types of Business Visa Immigrant that can be

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

pplied for:

1. Investors - this program is aimed at people with at least two years recent business experience and sufficient capital. Investors must have a minimum net worth of CDN $800,000 and make an investment of CDN $4

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

00,000 that is used by either the Provinces or Territories to boost the local economy. The C$400,000 investment is administered by the Citizenship and Immigration Canada and is returned to the “investor” after around 5 year

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

Combination pro

. No interest is paid as a zero interest promissory note will be issued to the applicant that is non transferable and has to be presented to the CIC for repayment of the C$400,000.

Though not mandatory, it is recommended t

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

hat a “facilitator” (authorized by the CIC and are normally representatives from one of the national banks) is used to represent the investor with no costs incurred – CIC will pay the fees.

Once you have proof of funds 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

must earn at least 35 points from the CIC selection table. After this, you must pass a medical and then the standard security and immigration checks. Provided you satisfy all these requirements, you will then be informed b

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

the CIC how to make the investment payment and once received, the permanent resident visa will be issued. Once awarded there are no extra conditions applied to your residency terms.

2. Entrepreneurs - this program is aime

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

d at experienced people who can create jobs and contribute to the Canadian economy by owning and managing profit orientated businesses. Entrepreneurs must have a minimum of two years business experience and a minimum net wo

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

th of CDN$300,000.

As with the investor program you must score at least 35 points from the CIC selection table. One major difference is that you will have to give a written brief of your intentions and how you will meet

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

Following aspects would a

given conditions of the Canadian business environment. Then, once you are resident, you will then have 3 years to physically fulfill these requirements.

During the initial 18 months of your residency you will be expected t

dd to the challenges in developing combination products:

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

o contact your local CIC office and give them firm evidence of the progress of your endeavours so far.

3. Self-employed persons - this program is aimed at people who can create their Own Employment, this may be by buying a

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

d running a farm in Canada for example. You must be able to show that you have a minimum of two years of relevant experience in the 5 years preceding the application. This relevant experience is limited to three distinct ar

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

eas. They must contribute to the cultural or athletic life of Canada (check the NOC classifications), be a world class athlete or have farm management experience.

There are several different aspects to this, the third clas

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 visa, from the other two. There are no further conditions once you have landed as a resident and you do not have to demonstrate any net worth requirements other than the standard settling funds required for your family.

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

Professional from academic institutions, pharmaceutical industries, health care indust

The Application Fee is non-refundable and is payable at the time of application. This applies to the principle applicant, any accompanying spouse or common-law partner and dependent children.

The second fee payable is th

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

e Right of Permanent Residence Fee, this fee is refundable if you cancel your application, Citizenship and Immigration Canada do not issue you the business visa or if you do not use your visa. It can be paid at any time dur

.

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

ng the application process but must be paid before your Permanent Residence visa can be issued and applies to the principle applicant, any accompanying spouse or common-law partner. All fees are payable in Canadian Dollars.

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

Companies that provide selfless information through particip

For more, detailed information on Canadian Business and Investor visa's please visit http://www.onestopimmigration-canada.com/business.html

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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Cases - Canadian Business and Investor Visa

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