Step 1: Your Business Plan
Prior to opening any pharmaceutical business in Canada, you will need a very detailed business plan. Your plan should include a very clear executive summary, an operational plan, your market analysis specific to Canada, your sale and marketing plan as well as your competitive analysis pertaining to your drug or service. See how we can help you review your plan with our go-no-go report.
Step 2: Register Your Business
You should register your business with the government of Canada and possibly the province where you intend to do business with them. Prior to your incorporation, you will need to decide what name you will choose for your business. You will need to check if your name is not already registered in the Canadian corporate names and trademark database. You will also need to search each provincial database to verify that the name of your corporation is not already taken.
Prior to your business registration, you will need to decide where your main office will be located. The majority of pharmaceuticals are located in Montreal or Toronto, as this is where the majority of pharmaceutical activities take place.The decision about the location is extremely important, since it can have both financial and legal consequences. You will also need to understand the local regulations (for example, doing business in Quebec might require you to work in French and communicate in French with your employees).
Step 3: Get Business Support and Financing
Building your network in Canada can be challenging. The pharmaceutical industry has many players, but building your own network is essential. Regional agencies promoting businesses can help and can even offer financial incentives if you decide to establish yourself in their proposed region. Innovation funding is also available in Canada and you will need to navigate through all the paper work to get these incentives. Finally, you will need a private bank to support your business and process all your future payments.
Step 4: Finding your Legal and Insurance Advisors
There are many legal firms in Canada specializing in pharmaceuticals. Many of them can charge you high fees since they might offer you a service you simply don’t need. However, getting legal advice from the start is fundamental. Finding a good legal advisor is important, since you want to keep a relationship that will hopefully last for many years.
Navigating through insurance can be a challenge. If you want to start clinical trials in Canada, you will need a special type of insurance. Although lawsuits are less of an issue in Canada than in the USA, it is important for you to understand your insurance contract in detail. Specialized insurance firms dedicated to pharmaceuticals are highly recommended.
Step 5: Applying for your Business Permits and Licenses
Once you get your business registration number, you will need to apply and keep track of all the required permits and licenses. This includes federal permits (such as federal corporations, export or importing permits, drug establishment licenses, as well as any additional licensure from Health Canada, and so on), provincial permits (such as lab accreditations), and municipal permits (construction, land, and so on).out what you need in terms of licensing can be challenging. Allow us to point you in the right direction.
Step 6: Start Selling your Medication
This can be harder than you think, since the health system in Canada is truly a maze with federal, provincial and even local players. Pricing and reimbursement is a world of its own (did you know that reimbursement is subject to complex federal and provincial regulations and once you sell the drug at a certain price, it is hard to change it?). Depending on the drug or service you want to sell, you will need to find out who buys it, what regulations set the price and even if you can participate in the tender process. Some medications can be directly sold to hospitals (i.e, medication under special access). We highly suggest having a detailed analysis of the pricing and reimbursement prior to your business registration. The option of licensing your medication to a Canadian company that is already familiar with the process and already has clients should be considered.
