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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

Client Work

  • Algernon Pharmaceuticals Inc. completes C$1.1 million marketed public offering,
  • Advent International acquires leading specialty chemicals solutions provider Caldic from Goldman Sachs Asset Management, Ongoing since November 2021
  • Kraft Heinz Co’s C$1.62 billion sale of its Canadian natural cheese business to Parmalat SpA,
  • Profound Medical completes US$17.4 million bought deal prospectus offering,
  • Global medical device manufacturer represented in complaint before Advertising Standards Canada,
  • Global medical device company assisted in relation to the suspension by Health Canada of its medical device licence,
  • Developing standard operating procedures for pharmaceutical companies,
  • Advising pharmaceutical manufacturers in the development of patient support programs,
  • Advising Japan based medical device manufacturer to enter new medical device in Canada,

Knowledge

News

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