Develop GMP for Start-up, export compliance, QMS Development to Health Canada requirements, preparation and hosting for Health Canada inspection and final DEL certification

Client Type: Pharmaceuticals, GxP System

Jurisdiction(s): Canada

Services Provided: Performed a Compliance Gap Analysis to support business needs. Reviewed products under business and profile for regulatory compliance for export. Reviewed contracts and Quality Agreements, prepared QMS procedures and associated forms for attestation prior to DEL application for wholesale. Prepared GMP records for inspection and personnel and provided GDP and GMP training. Hosted the Health Canada inspection and handled corrective actions with Health Canada. DEL amendments were also performed along with ongoing QA.