Regulatory Affairs in Life Sciences

Fasken delivers practical solutions and strategic advice to meet the unique regulatory considerations that our life sciences clients must contend with at every stage of the product lifecycle.

Overview

As business goes global and more rules come into play, it can be a challenge to keep up.

We advise on the regulatory aspects of each product development stage as products move from clinical development through to approval and commercialization. We advise on clinical trials, market authorization, pricing and reimbursement, post-market vigilance, advertising and promotion, product claims and labeling, quality management and ethical industry standards. We also negotiate and draft related commercial agreements, and advise on how regulatory considerations should be factored into investment, funding or other opportunities. Our extensive expertise includes responding to enforcement activities by government regulators and industry associations.

Our team is comprised of professionals with advanced scientific degrees and in-house experience at international drug and medical device companies.

Our clients include stakeholders in the drug, medical device, natural health product, cosmetics, food & beverage, veterinary product, human tissues and cannabis industries.

Read our publications, browse some of our recent life sciences work we’ve assisted with or contact any of our lawyers to learn more.

Team

Primary Contacts

Mathieu Gagné, Partner | Co-Leader, Life Sciences, Montréal, QC, +1 514 397 7657, mgagne@fasken.com
Timothy M. Squire, Partner | CO-LEADER, LIFE SCIENCES, Toronto, ON, +1 416 868 3462, tsquire@fasken.com
Ingrid E. VanderElst, PhD, Partner | Trademark Agent | Intellectual Property, Toronto, ON, +1 416 865 4519, ivanderelst@fasken.com

Mathieu Gagné Partner | Co-Leader, Life Sciences Montréal, QC +1 514 397 7657
mgagne@fasken.com

Timothy M. Squire Partner | CO-LEADER, LIFE SCIENCES Toronto, ON +1 416 868 3462
tsquire@fasken.com

Ingrid E. VanderElst, PhD Partner | Trademark Agent | Intellectual Property Toronto, ON +1 416 865 4519
ivanderelst@fasken.com

All Members

Client Work

Algernon Pharmaceuticals Inc. completes C$1.1 million marketed public offering, [Deal - Algernon Pharmaceuticals Inc.], Clinical stage drug re-purposing company closes marketed public offering
Advent International acquires leading specialty chemicals solutions provider Caldic from Goldman Sachs Asset Management, [Deal - Advent International], Advent International is one of the largest and most experienced global private equity investors.
Kraft Heinz Co’s C$1.62 billion sale of its Canadian natural cheese business to Parmalat SpA, [Deal - Kraft Heinz Canada Inc.], On Tuesday, July 2, 2019 Kraft Heinz Canada Inc. completed the previously announced C$1.62 billion sale of its Canadian natural cheese business to Parmalat Canada Inc. The transaction followed a competitive bidding process, and included the sale of well-known natural cheese brands Cracker Barrel,...
Profound Medical completes US$17.4 million bought deal prospectus offering, [Deal - GMP Securities L.P.], On November 14, 2016, Profound Medical Corp. completed a bought deal short form prospectus offering of 15,820,000 common shares (the “Common Shares”) at an issue price of $1.10 per Common Share for aggregate gross proceeds of $17,402,000 (the “Offering”). The Offering was conducted by a syndicate...
Global medical device manufacturer represented in complaint before Advertising Standards Canada, [Case - Confidential Client], Fasken Martineau was retained by a major medical device manufacturer to assist with various aspects relating to an advertising dispute. Fasken Martineau provided strategic advice throughout the dispute resolution process and represented the client at a resolution meeting before Advertising Standa...
Global medical device company assisted in relation to the suspension by Health Canada of its medical device licence, [Case - Confidential Client], Fasken Martineau was retained by a major medical device manufacturer to assist with various aspects relating to the suspension by Health Canada of its medical device licence (marketing authorization) as well as various Health Canada inspections of its manufacturing sites (in Canada and the U.S.) ...
Developing standard operating procedures for pharmaceutical companies, [Case - Confidential Client], Fasken Martineau was retained by a US manufacturer of prescription drugs in connection with an internal compliance investigation of its Canadian subsidiary. Fasken Martineau assisted in conducting interviews with key employees to assess compliance with Health Canada policy and procedures. In para...
Advising pharmaceutical manufacturers in the development of patient support programs, [Case - Confidential Client], Fasken Martineau was retained by multiple Canadian drug and U.S. drug manufacturers to help development patient support programs aimed at supplying drugs to patients after a notice of compliance has been issued by Health Canada and prior to listing on provincial drug formularies. Fasken Martineau...
Advising Japan based medical device manufacturer to enter new medical device in Canada, [Deal - Confidential Clients], Fasken Martineau was retained to assist a Japanese based medical device manufacturer with Canadian market entry of new Class III medical device including product license analysis and classification. As a result of Fasken Martineau’s services, the medical device obtained Health Canada approval in ...

Deal July 2022 Advised Algernon Pharmaceuticals Inc. Algernon Pharmaceuticals Inc. completes C$1.1 million marketed public offering Clinical stage drug re-purposing company closes marketed public offering Read more

Deal Ongoing since November 2021 Advising Advent International Advent International acquires leading specialty chemicals solutions provider Caldic from Goldman Sachs Asset Management Advent International is one of the largest and most experienced global private equity investors. Read more

Deal July 2019 Advised Kraft Heinz Canada Inc. Kraft Heinz Co’s C$1.62 billion sale of its Canadian natural cheese business to Parmalat SpA On Tuesday, July 2, 2019 Kraft Heinz Canada Inc. completed the previously announced C$1.62 billion sale of its Canadian natural cheese business to Parmalat Canada Inc. The transaction followed a competitive bidding process, and included the sale of well-known natural cheese brands Cracker Barrel,... Read more

Deal November 2016 Advised GMP Securities L.P. Profound Medical completes US$17.4 million bought deal prospectus offering On November 14, 2016, Profound Medical Corp. completed a bought deal short form prospectus offering of 15,820,000 common shares (the “Common Shares”) at an issue price of $1.10 per Common Share for aggregate gross proceeds of $17,402,000 (the “Offering”). The Offering was conducted by a syndicate... Read more

Case January 2016 Represented Confidential Client Global medical device manufacturer represented in complaint before Advertising Standards Canada Fasken Martineau was retained by a major medical device manufacturer to assist with various aspects relating to an advertising dispute. Fasken Martineau provided strategic advice throughout the dispute resolution process and represented the client at a resolution meeting before Advertising Standa... Read more

Case December 2015 Represented Confidential Client Global medical device company assisted in relation to the suspension by Health Canada of its medical device licence Fasken Martineau was retained by a major medical device manufacturer to assist with various aspects relating to the suspension by Health Canada of its medical device licence (marketing authorization) as well as various Health Canada inspections of its manufacturing sites (in Canada and the U.S.) ... Read more

Case April 2015 Represented Confidential Client Developing standard operating procedures for pharmaceutical companies Fasken Martineau was retained by a US manufacturer of prescription drugs in connection with an internal compliance investigation of its Canadian subsidiary. Fasken Martineau assisted in conducting interviews with key employees to assess compliance with Health Canada policy and procedures. In para... Read more

Case March 2015 Represented Confidential Client Advising pharmaceutical manufacturers in the development of patient support programs Fasken Martineau was retained by multiple Canadian drug and U.S. drug manufacturers to help development patient support programs aimed at supplying drugs to patients after a notice of compliance has been issued by Health Canada and prior to listing on provincial drug formularies. Fasken Martineau... Read more

Deal February 2015 Advised Confidential Clients Advising Japan based medical device manufacturer to enter new medical device in Canada Fasken Martineau was retained to assist a Japanese based medical device manufacturer with Canadian market entry of new Class III medical device including product license analysis and classification. As a result of Fasken Martineau’s services, the medical device obtained Health Canada approval in ... Read more

All Client Work

Knowledge

New PMPRB Draft Guidelines Set Out Administrative Process for Excessive Price Hearing Recommendation, 12/30/2024
Federal Court of Appeal Rules That PMPRB Has No Jurisdiction Over Unpatented Medicine Prices: The End of the “Slender Thread” Test, 12/9/2024
Federal Pharmacare Is Now Law, 10/15/2024