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+1 416 593 5514About
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
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Nationwide - Canada
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