About

Provided by Smart & Biggar

Smart & Biggar is Canada's largest firm practicing exclusively in IP and technology law and we are experts in navigating the complex Canadian regulatory environment.

Our regulatory and compliance services include:

  • Regulatory (Health Canada and provincial) and health care compliance advice
  • Reimbursement, interchangeability, rebate and procurement advice
  • Marketing and advertising, including programs with HCPs and patients, disease awareness initiatives, collaboration agreements, PR communications, Direct-to-Consumer advertising campaigns, and Innovative Medicines Canada (IMC) and Pharmaceutical Advertising Advisory Board (PAAB) matters
  • Brand name assessments including Look-alike Sound-alike (LA/SA) Assessments of product names
  • Access to Information Act and Freedom of Information and Protection of Privacy Act matters
  • Regulatory due diligence
  • Data protection advice and responding to eligibility rejections by the Office of Patented Medicines and Liaison (OPML)
  • Patent listing under the Patented Medicines (Notice of Compliance) Regulations, including preparation of forms and responding to objections by the OPML
  • Certificates of supplementary protection, including preparation of applications
  • Patented Medicine Prices Review Board (PMPRB) advice
  • Submissions on draft statutory and regulatory amendments
  • Applications for judicial review

We assist our clients with all relevant government agencies, including:

  • Health Canada
  • PMPRB
  • Provincial insurers
  • Regulatory colleges for health care professionals
  • OPML

Ranked Lawyers at
Smart & Biggar

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Nationwide - Canada

Life Sciences: Regulatory/Compliance

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Members

Provided by Smart & Biggar

Daphne Lainson

Head of Department

David Schwartz

Mark Pidkowich

Nancy Pei

Sheldon Hamilton

Yoon Kang

Industries

Provided by Smart & Biggar

Cannabis

Chemical & Biotechnology

Pharmaceutical & Biologics