Our Services
- Preparation and filing of submissions for prescription and nonprescription drugs, biologics, natural health products, cosmetics and medical devices (Clinical Trial Applications, New Drug Submissions, Supplemental New Drug Submissions, Abbreviated New Drug Submissions (generics), post-approval change submissions/amendments, submission for "old drugs", natural health Product License Applications, Medical Device Licences, Cosmetic notifications)
- Organizing, planning and participation in pre-submission meetings on behalf of sponsors
- Regulatory submission strategy
- Preparation, update, revision and annotation of Product Monographs, Investigator Brochures and Package Inserts/Consumer Information
- Preparation and review of product labelling for drugs, biologics, natural health products, cosmetics, and devices
- Regulatory gap analysis of US or European dossiers for suitability of submission to Health Canada
- Contact, negotiation and consultation with Health Canada
- Due diligence of regulatory documentation of products prior to a potential acquisition
- Regulatory compliance activities for post-approval needs
- Preparation of Provincial Formulary submissions
- Regulatory training courses
- Monitoring of pre-clinical and clinical studies
- Clinical protocol writing/medical writing