Department profile
Smart & Biggar

Life Sciences: Regulatory/Compliance

Canada Guide 2026 : Nationwide - Canada

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Smart & Biggar

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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

Industries (3)

  • Pharmaceutical & Biologics
  • Cannabis
  • Chemical & Biotechnology

Chambers Review

Provided by Chambers

Life Sciences: Regulatory/Compliance - Nationwide - Canada

What the Team is Known For

Smart & Biggar is a well-respected IP boutique with an impressive following of clients involved in life sciences, including those active in the cannabis and agribusiness sectors. With patent expertise sought after by pharmaceutical and biotech companies big and small, the law firm has significant experience representing clients in complex patent infringement cases, as well as portfolio management and prosecution. It also maintains a well-regarded regulatory practice, advising on product licensing, advertising, commercialisation and compliance with regulatory regimes. The firm has offices in Toronto, Ottawa, Waterloo, Vancouver, Calgary and Montréal.

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Strengths

Provided by Chambers

  • Smart & Biggar is always timely in responses and proactively reaches out to understand client needs.

    Life Sciences: Regulatory/Compliance respondentCanada

  • The team at Smart & Biggar has deep knowledge and experience in pharmaceutical sciences and business-focused counsel.

    Life Sciences: Regulatory/Compliance respondentCanada

  • It's been extremely productive working with Smart & Biggar; they're so good and helpful. They promptly respond to our requests and keep up to date with what we're doing.

    Life Sciences: Regulatory/Compliance respondentCanada

Notable Practitioners

Provided by Chambers

  • Alice Tseng
    Alice Tseng

    Alice Tseng

    Toronto-based Alice Tseng maintains a market-leading regulatory practice in the life sciences sector, advising on matters ranging from the licensing and commercialisation of products to advertising and issues of privacy.

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Ranked Individuals at Smart & Biggar (1)

Nationwide - Canada

Members

Provided by Smart & Biggar

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