Quality Assurance System
Regxia has created a Canadian Quality Services department that provides a host of services to the small to mid-sized company. Our customers can choose services that range from SOP development to full QA support wherein Regxia can provide a complete surrogate QA department for their Canadian activities.
1
Drug Establishment Licensing (DEL) Coordination & Management
Regxia’s quality group is able to manage all aspects of your DEL application including SOP development, coordination of required site listings, supporting documentation, product compliance files, and inspection coordination.
2
Health Canada GMP Inspections
Regxia will manage your initial and subsequent Health Canada GMP Inspections. Our team is able to consult with clients post-inspection to negotiate and provide strategic solutions/responses to inspection observations.
3
Ongoing Compliance
Regxia will handle finished product releases for sale to the Canadian market, investigations and deviations, coordinate confirmatory testing, and review/produce Annual Product Quality Reports (APQRs).
4
Quality / Technical Agreements
Regxia’s experienced team will develop, review and facilitate the implementation of compliant Quality/Technical Agreements between your company and third parties.