MBM's Regulatory Practice Group

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.