Time-sensitive and strategic regulatory planning is key to the successful launch and continued commercial success of a product or service.
Members of Blaney’s Regulatory and Compliance practice guide clients through Canada’s complex and ever-changing regulatory landscape for drugs, medical devices, natural health products, cosmetics, food, veterinary products, and consumer goods. Many of our lawyers draw on their scientific backgrounds and first-hand industry experience in order to understand their clients’ needs and develop a regulatory and compliance strategy that works for both clients and regulators. Our lawyers also have extensive experience in negotiating with regulatory authorities and advocating for their clients.
We offer regulatory and compliance support throughout a product’s lifecycle – from product development and manufacturing to market approval – and beyond. We also have a large team of highly skilled and experienced litigators.
We support our clients with various regulatory and compliance issues, including:
- Pharmaceutical, medical device and natural health products licensing;
- Regulatory strategies for pharmaceuticals, medical devices, natural health products, cosmetics, food, veterinary products, and consumer goods;
- Quality control and quality assurance strategies, including compliance with prescribed Good Manufacturing Practices and Good Laboratory Practices;
- Establishment site licensing;
- Product recalls and detentions;
- Judicial review applications;
- Packaging, labelling, marketing and advertising matters;
- Regulatory and compliance issues relating to clinical trials;
- Quality, regulatory and compliance issues relating to importation, distribution and warehousing;
- Pharmaceutical pricing and provincial formulary listings, including representation before the Patented Medicine Prices Review Board (PMPRB); and
- Environmental site compliance.