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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.
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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, Toronto, ON, +1 416 865 4519, ivanderelst@fasken.com

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.]
  • Profound Medical completes US$17.4 million bought deal prospectus offering, [Deal - GMP Securities L.P.]
  • Global medical device manufacturer represented in complaint before Advertising Standards Canada, [Case - Confidential Client]
  • Global medical device company assisted in relation to the suspension by Health Canada of its medical device licence, [Case - Confidential Client]
  • Developing standard operating procedures for pharmaceutical companies, [Case - Confidential Client]
  • Advising pharmaceutical manufacturers in the development of patient support programs, [Case - Confidential Client]
  • Advising Japan based medical device manufacturer to enter new medical device in Canada, [Deal - Confidential Clients]

Knowledge

News

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