Regulatory Affairs
Regulatory compliance can be overwhelming and confusing to maintain; FPR provides timely guidance to keep your company afloat of the rapidly changing Canadian regulatory environment. FPR acts as an interface between industry and Health Canada in applying regulatory strategy to bring your products to market efficiently and in a competitively regulated manner. We understand that regulatory delays diminish product profitability, so we anticipate emerging regulatory issues to expedite your product’s conception to the market cycle.
Focal Point Research Inc. offers a wide range of Canadian, US and EU regulatory affairs services in: 
- Cosmetics
- Drugs
- Natural Health Products
- Medical Devices
- Consumer Products
Specific services include:
Regulatory Submissions and Applications
- Prepare submissions for Cosmetic Notifications, Drug Identification Numbers (DINs), Natural Health Product numbers (NPNs), Medical Device license registrations, and Pest Control Product Number submissions
- Ensure US compliance for Dietary Supplement reviews & registration, Cosmetic labeling, Over The Counter Drugs
- Apply for Drug Establishment Licenses and Site Licenses
- Submit applications for manufacturing, packaging and warehousing facility approvals for Drugs and Natural Health Products
- Preparation of EU Dossiers
Regulatory and Quality Management
- Represent client to government agencies
- Prepare Standard Operating Practices (SOPs)
- Conduct Drug GMP inspections and host inspections from Health Canada
- Manage issues and crises including product recall, challenges from competitors, media, or lobbyists
Labeling & Marketing Review
- Review all marketing materials for compliance and claim maximization
- Ensure labels and marketing comply with Canadian standards
Training
- Conduct on-site training for Good Manufacturing Practices, consumer complaint handling and other aspects of compliance