A successful intellectual property strategy always complies with regulatory rules and laws
We are experts in navigating the complex Canadian regulatory environment.
In the strict and constantly changing regulatory environment for pharmaceuticals and biologics in Canada, expert regulatory and compliance advice and counselling is essential to maximize commercial opportunities while minimizing unnecessary risk.
Drawing on our extensive legal and litigation expertise in regulatory areas, we provide an integrated team approach and a level of technical depth and support for our Canadian and international clients that is unmatched in Canada.
Our lawyers have deep expertise in managing issues that arise at the pharmaceutical/biologic patent-regulatory interface. We offer our clients expert assistance and targeted advice, helping to develop and implement policies to ensure best practices. We also have extensive experience drafting submissions on proposed regulatory amendments. In addition, if necessary, our experienced litigators will pursue judicial reviews before federal, provincial and appellate courts.
We recognize the importance of coordinating patent prosecution and enforcement with regulatory and market status of pharmaceutical and biologic drug products, throughout a product’s life cycle, from early clinical development to regulatory approval to litigation and beyond.
In our regulatory and compliance practice we work with and advise clients on matters that extend to and include pharmaceuticals (small molecules), biologics, Advanced Therapeutic Products, controlled drugs and substances, medical devices, natural health products and veterinary products.
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
- Patented Medicine Prices Review Board
- Provincial insurers
- Regulatory colleges for health care professionals
- The Office of Patented Medicines and Liaison
We advise on all applicable legislation, including:
- The Food and Drugs Act
- Provincial reimbursement (e.g. Ontario Drug Benefit Act, Drug Interchangeability and Dispensing Fee Act)
- Laws governing health care professionals (e.g. Medicine Act, Drug and Pharmacies Regulation Act)
- Access to Information Act
- Freedom of Information and Protection of Privacy Act
Key Contacts
Unparalleled Expertise in Life Sciences Regulatory & Compliance
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Lexpert
19 Lexpert®-ranked lawyers
2022-2023Lexpert Special Edition: Technology and Health Sciences -
Who's Who Legal
Four Life Sciences leaders
2023Who's Who Legal: Life Sciences -
Who's Who Legal
Six Thought Leaders in Patents, Trademarks & Life Sciences
2023WWL Thought Leaders: Global Elite -
Who's Who Legal
16 leading IP experts
2022Who's Who Legal: Canada -
Who's Who Legal
17 leading IP experts
2022Who's Who Legal: IP -
Who's Who Legal
Five Life Sciences leaders
2018-2022Who's Who Legal: Life Sciences -
Who's Who Legal
Four Thought Leaders in Patents and Trademarks
2022WWL Thought Leaders: Global Elite -
Who's Who Legal
17 leading IP experts
2020-2021Who's Who Legal: Canada -
Who's Who Legal
17 leading IP experts
2021Who's Who Legal: IP -
Lexpert
Nine Lexpert®-ranked lawyers
2021Lexpert Special Edition: Health Sciences
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Release of Statistical Report 2023/2024 for PMNOC Regulations, data protection and CSPs
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Smart & Biggar boasts 21 lawyers and agents recognized as leaders for IP in Who’s Who Legal: Canada Guide 2023
Smart & Biggar is proud to be featured as a leader in IP in the recent edition of Who’s Who Legal (WWL) Canada Guide 2023. In total, 21 of our lawyers and patent agents have been recognized across...Read More -
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