Regulation is a significant component of the life sciences industry and one of the core specialties of Fasken Martineau’s Life Sciences group. With regulatory specialists in Vancouver, Toronto, Montréal, London and Paris, we are at the forefront of pharmaceutical, medical device, cosmetics, food, biologic and natural health product regulations in Canada and the EU.
Our highly specialized group includes professionals with advanced degrees in chemistry, biochemistry, microbiology and pharmacy as well as professionals with in-house experience at international drug and medical device companies. We advise on the regulatory aspects of all stages of product development, approval and commercialization including quality, safety and efficacy issues and as pricing and reimbursement matters.
We offer a sophisticated understanding of the regulatory complexities of the health product lifecycle and of the commercial context within which our advice is required. These insights inform the advanced strategic advice and practical regulatory solutions we deliver to achieve your business objectives within the highly competitive life science industry.
Our regulatory lawyers advise large, mid-sized and smaller pharmaceutical, biotechnology and medical device companies as well as business in the natural health products, food supplements and cosmetic industries.
- Clinical trial approval and investigational testing authorizations
- IRB/REB/IEC submissions
- CRO, institutional and investigator contracts
- New and abbreviated new drug submissions
- Medical device approvals
- Natural health product licensing and compliance
- Drug/device combination products and borderline challenges
- Natural Health Product/Food interface product challenges
- Data protection/exclusivity in relation to generics and biosimilars
- QMS certification and requirements
- PMBRB reporting and advocacy
- Public formulary eligibility and listing agreements
- Interchangeability and standing challenges
- Transactional regulatory due diligence
- Product acquisition and licensing
- Manufacturing, distribution and quality agreements
- AE reporting and domestic/international product recalls
- Prescription drug advertising restrictions
- Corporate governance and anti-corruption programs
- Sample distribution and compliance
- Counterfeiting and illegal distribution