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.
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.
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.
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).
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.