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Industries

Regulatory Affairs in Life Sciences

Fasken

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.