MBM's Regulatory Practice Group

MBM services single regulatorypractice

MBM's Regulatory Practice Group advises clients on a broad range of regulatory issues related to drugs, natural health products, medical devices/diagnostics, food and cosmetics.  It is comprised of a multidisciplinary group of practitioners with past experience working at Health Canada in the application and enforcement of the Food & Drug Act and associated regulations, as well as working within major pharmaceutical companies:

Our expertise includes, but is not limited to, the following:

  • Classification of products under the various regulatory regimes;
  • Manoeuvring through the regulatory approval process including pre-submission and submission activities with regulatory authorities and appeals of submission decisions;
  • Patent listing under the Patented Medicines (Notice of Compliance) Regulations and eligibility for data protection/exclusivity; and
  • Application of the Patented Medicine Prices Review Board and formulary listing and reimbursement. 

 

 

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RANDALL MARUSYK

Partner


Randall is a partner of the firm and has been certified as a specialist in all areas of Canadian IP Law.
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