Is my foreign contact reliable?

In this week’s Ask the TCS column, a Canadian company needs to get FDA approval for its new over-the-counter gel. The company found a consultant to handle its FDA application but asks the TCS, “Is this contact reliable?”

Dear Ask the TCS,

We are an entrepreneurial Canadian company and have just developed a topical pain relieving gel that we want to export to the U.S. We understand that the product will need to be registered with the U.S. Food and Drug Administration (FDA). We have found a company (referred to as “Company X”) in the U.S. that we think can handle our FDA application process. Can you let us know if “Company X” is reliable?

Thank you,

Gwynne MacHattie

Cynthia Stevenson, Trade Commissioner at the Canadian Embassy in Washington D.C., writes:

Cynthia Stevenson

Dear Gwynne,

Thanks for your email. Finding qualified contacts is one of the ways the Trade Commissioner Service can help export-ready Canadian companies. We know that it can take months (and a lot of money) for companies to find the right contact. And once you’ve found them, it’s nice to know you’re dealing with qualified and reliable people.

As a Trade Commissioner with sector responsibility for medical devices and health IT sectors in the mid-Atlantic U.S., I am always pleased to assist companies seeking advice on the FDA approvals process for their medical devices and technologies. While we can’t officially recommend a firm to work with, we can provide you with information about the company. In this case, I had not heard of your company so I contacted two informed sources.

My first source is a well-respected FDA consultant with whom I have an established relationship on behalf of my Canadian industry clients. She had not heard of “Company X” either. We noticed certain discrepancies on “Company X’s” website regarding its fee structure and a lack of clarity about its capabilities to undertake more complex regulatory processes on behalf of its clients.

I also asked another key source of mine who is a senior official at the FDA’s Center for Devices and Radiological Health for any comment he might have. Although the FDA does not keep a list of approved consultants nor is the agency permitted to recommend consultants to companies, my contact did note that “Company X” has an established relationship with the FDA on behalf of its industry clients, so clearly this is not a “fly-by-night” organisation.

That said, we advise all Canadian firms entering into contractual agreements with industry consultants to conduct due diligence on the prospective partner before entering into a business relationship with them, and I would encourage you to do this before engaging the services of “Company X”.

We also encourage Canadian companies seeking business partnerships in the U.S. and abroad, to visit our website at for an array of information and resources that include access to sector experts in our 18 Regional Offices across Canada.

Our sector expert at your nearest Regional Office can assist with the development of your U.S strategy and business plan to help lower the risk of entry to a market that is huge, sophisticated and highly competitive – but also very rewarding for companies that are well prepared to do business here.

I also recommend that you register for our Virtual Trade Commissioner. This is a personalized online gateway that will connect you to the trade commissioner in your target market. You can also receive market reports and news of trade events and other sector-specific information that you may find useful.

I hope this information is helpful, Gwynne. I wish you every success in your U.S. business endeavours and look forward to hearing of your progress. Please feel free to contact me at any time if I can be of further assistance.



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