REGULATORY AFFAIRS

ROBIC is among the few Canadian law firms structured to provide counsel on all aspects of its client’s intangible assets, from intellectual property to regulatory matters.

Our familiarity and in-depth knowledge of the mechanics that drive regulated industries enable us to provide our clients with a compliance perspective to their IP and related commercial endeavours.

Our Regulatory practice comprises a team of highly specialized IP professionals representing clients in different regulated industries, advising them on all matters specific to their legal landscape, from counseling on market access to providing strategic input on matters involving a regulatory agency.

ROBIC is also a member of many industry trade associations where our professionals are routinely solicited to participate and provide input on a variety of topics relevant to our clients commercial and regulatory realities.

We are here to support innovation though compliance in the following regulated fields:

Life Sciences (Drugs, Natural Health Products, Cosmetics, Medical Devices, Novel Therapies, Controlled Substances, Agricultural Sciences)

• Market Access, Licensing and Authorisation strategies
• Counselling on commercial activities governed by Health Canada
• Data Exclusivity, Innovative Drug Status reviews
• PM(NOC) litigation support
• Special Access to Controlled Substances
• Plant, seed and Environmental compliance

Food, Beverage, Alcohol, Tobacco, Vaping Products and Cannabis

• Guidance on novel product categories and Industry guidelines
• Market Access and post market support
• Quality compliance management and strategic counsel
• Enforcement matters with the regulatory agencies

Advertising, Marketing, Labelling, Publicity Contests and Language matters

• Pre-clearance and reviews of industry specific advertising and marketing materials
• Publicity contest rules, review and pre-clearance
• Product Labelling clearance and claim support reviews
• Language matters involving the Quebec Charter of the French Language
• Assistance with matters involving the PAAB, Ad Standards Canada, the Competition Bureau and related agencies

Telecommunication, Industry Standards, Data & Privacy and Radiocommunication

• Compliance with device/industry standards
• Review of telecommunication rules, guidelines and assessments
• Privacy policy, data collection and personal information management

For all enquiries as to a specific regulatory legal service that we provide at ROBIC, please contact the practice chair: Jason Moscovici