Drugs, Medical Devices, Cosmetics & Natural Health Products
Canadian regulatory counsel advising:
- Canadian subsidiary of a prominent European pharmaceutical and medical devices company, including on multiple complaints to Health Canada and the Pharmaceutical Advertising Advisory Board from and against competitors regarding product non-compliance, on conducting Canadian clinical trials, and on negotiating clinical research organization (CRO) and investigator agreements
- U.K. pharmaceutical company in a Canada-specific drug product recall, including coordination with Health Canada’s Therapeutic Products Directorate and negotiations with Canadian distributors
- European biotechnology company conducting pharmaceutical clinical trials in Canada, including structuring proposed agreements with the CRO, the investigators and the clinical trial subjects, and counselling on related personal health information privacy matters
- Pet nutrient products manufacturer in respect of Canada Border Services Agency (CBSA) product seizures and Health Canada rulings on product classification under the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR)
- U.S. manufacturer conducting medical device clinical trials in Canada, including on federal government practices and policy directions, and on negotiating associated CRO and investigator agreements
- U.S. medical devices and personal care products manufacturer, including on device performance testing, performance claims and marketing
- U.S. radiographic imaging equipment manufacturer on obtaining federal and provincial product approvals
- Global luxury cosmetics company on all product compliance, marketing and regulatory notice matters
- Numerous companies in connection with the classification, registration and regulation of natural health products
Food & Food Services
Canadian regulatory counsel advising:
- Global and Canadian branded foods products manufacturer on all FDA/FDR packaging and labelling compliance, on enforcement actions, including a Health Canada fish product imports seizure and a Quebec authority dairy products compliance action, on negotiating co-packing and other commercial agreements related to food production operations, on tariff classification matters and dairy product import quota matters
- Global and Canadian food distributor, including on food transportation and storage compliance matters and on drafting its food product recall compliance manual
- Canadian dairy products producer in a Listeria monocytogenes contamination recall and related Health Canada investigation
- Global and Canadian cocoa and chocolate products manufacturer in connection with a Canadian Food Inspection Agency (CFIA) allergen labelling enforcement action
- Major Canadian branded foods products manufacturer in a mycotoxin contamination recall
- Leading North American restaurants company in a Health Canada compliance action concerning poultry products marketing
- Multi-national spirits company on alcohol products, import, distribution, marketing and sales regulatory matters
Other Regulated Products
Canadian regulatory counsel advising:
- Global chemicals manufacturer, including on regulatory processes and substantive submissions under the Canadian Environmental Protection Act and a related proposed Federal Court judicial review
- Leading global branded consumer packaged goods manufacturer on regulatory compliance under the Pest Control Products Act and the FDA
- Significant North American apparel and home accessories company, including on recalls of children’s jewellery, footwear, furniture and other products, and on the development of related compliance programs
- European cellular phone and related products supplier expanding into Canada, including on all regulatory standards, packaging and labelling
- Major North American pet food supplier on product compliance and marketing claims
- Global computer battery supplier on Canadian product recall
- Major U.S. lighting manufacturer on Canadian product recall
- Global small appliance manufacturer on electrical appliances product recall
- Major gas fittings and equipment manufacturer on the review of standards organization decisions in accordance with American National Standards Institute rules
