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.
