GxP Solutions offers a variety of compliance-based services:
GMP Support:
Tailor the following to your company’s operation, and maintain documentation:
- Change Control
- Deviations, OOS and related Investigations
- CAPAs
- Complaint Process
- Product Return/Disposition
- Recall Management
- Health Inspection Readiness / Preparation
- Releases (Drug, Medical Devices, NHP, Clinical IMPs)
- Label Review (English and French)
- Medical Devices
- Establishment License Preparation and Renewal
- GMP Training / Development of Annual Training Plan
- Yearly Quality Reviews (Product and Biologic)
- Establishment License Application and Renewal
- Process Improvement
- Validation
- Vendor Management (qualification and maintenance for Manufacturers, Packagers/labellers, Testers, Distributors, Clinical sites and Wholesalers)
- Coordinate Annual Confirmatory Testing
- Develop, review and facilitate the implementation of appropriate Quality/Technical Agreements between your company and third party contractors;
Technical Writing / Documentation Services:
- SOP / Work Instruction / Policy Development and Training
- Form creation
- Label and Marketing Piece review complying with PAAB and Health Canada Advertising Regulations
- Develop, Review and Facilitate the implementation of appropriate Quality/Technical Agreements between your company and third party contractors
Cold Chain Management Services:
- Ensure compliance with Guide 0069 and other Health Authority regulations and requirements