Quality Compliance

Drugs, Natural Health Products, Medical Devices

Quality Management System (QMS) Design & Maintenance (GMP, GLP, GCP, GVP)

ISO13485:2003 Certification for Class II, III, IV Medical Devices

Annual Product Quality Reviews (APQR)

Chemistry, Manufacturing & Controls (CMC)

Technical Quality Agreements

Batch Documentation

Validation Support (Computer System, Process, etc.)

Personnel Training

Audit Support (Regulatory Agencies, Supplier Qualification, Self-Inspections)