Regulatory Expertise

What We Do

Self-Care Categories Covered

Natural health products (NHPs), DIN products (non-prescription drugs), foods, medical devices, cosmetics, and veterinary health products (VHPs).

Classification & Pathway to Market

Precise product classification, route selection (DIN/NHP/device/food/cosmetic/VHP), and strategies for expanded therapeutic use.

Pharmacovigilance & Safety Reporting

SAE/SUSAR intake and case management, medical review, unblinding pathways.
DSUR/ASR, signal management, safety governance.

Evidence & Literature Support

Targeted public-domain literature searches and evidence summaries to strengthen licence applications.

Submissions & Lifecycle Management

New filings, amendments, notifications, and responses to Clarimails/IRNs (Health Canada information requests) and NoDs (Notices of Deficiency).

Compliance & Enforcement

Practical remediation plans, corrective actions, and regulator engagement to resolve issues quickly.

Provincial Scheduling & Rx→OTC Switches

Strategy, data expectations, and dossier preparation for scheduling decisions and switch submissions.

Product & Site Licensing

End-to-end support for product licences/registrations and site licences (set-up, renewal, inspections).

Regulatory Landscape Monitoring

Proactive scans of Health Canada updates, guidance changes, and policy trends—translated into clear action items.

Expert services

Expert-witness testimony and health-care professional advocacy to communicate benefits, risks, and appropriate use.