Regulatory Solutions
Consulting firm (founded 2001) providing regulatory affairs and compliance services to companies seeking Canadian approvals for prescription drugs, natural health products and medical devices. Services include regulatory submission preparation, dossier gap analysis and project management, GMP/compliance consulting for importers and distributors, SOP/QMS development and electronic submission support.
Industries
Nr. of Employees
small (1-50)
Regulatory Solutions
Caledon, Ontario, Canada, North America
Services
Submission preparation and support for new and generic drug approvals in Canada; dossier review, gap analysis and project management for Health Canada filings.
Regulatory planning and application support for DINs and natural health product applications, including label review against current Health Canada requirements.
Submission support for Class II, III and IV medical devices, including risk-based classification confirmation and compliance advice during Health Canada review.
GMP compliance consultation, organization and supervision of Health Canada audits, SOP creation, GMP training and assistance obtaining establishment/site licences.
Submission preparation and support for new and generic drug approvals in Canada; dossier review, gap analysis and project management for Health Canada filings.
Regulatory planning and application support for DINs and natural health product applications, including label review against current Health Canada requirements.
Submission support for Class II, III and IV medical devices, including risk-based classification confirmation and compliance advice during Health Canada review.
GMP compliance consultation, organization and supervision of Health Canada audits, SOP creation, GMP training and assistance obtaining establishment/site licences.
Expertise Areas
- Regulatory affairs for pharmaceuticals
- Regulatory submissions for medical devices
- Natural health product and OTC regulatory planning
- Good Manufacturing Practices (GMP) compliance
Key Technologies
- eCTD electronic submissions
- Common Electronic Submission Gateway (CESG) integration
- Regulatory dossier management
- Quality management systems (QMS) and SOP frameworks
News & Updates
Company established in 2001 providing regulatory affairs and compliance consulting.
Helped over 20 companies obtain or renew Drug Establishment Licences, Medical Device Establishment Licences and Site Licences.
Company established in 2001 providing regulatory affairs and compliance consulting.
Helped over 20 companies obtain or renew Drug Establishment Licences, Medical Device Establishment Licences and Site Licences.