Propharmex

Quality System & Good Manufacturing Practices

At Propharmex, we provide end-to-end Quality and Good Manufacturing Practices (GMP) support tailored to pharmaceutical, biologics, natural health products (NHPs), and medical device industries. Our team of regulatory and quality experts ensures your operations meet Health Canada, FDA, EMA, and international GMP standards to facilitate timely market access and maintain product integrity.

Propharmex played a pivotal role in establishing and managing regulatory affairs and quality assurance systems for international companies expanding into Canada. To date, Propharmex has guided several organizations through successful acquisition of Drug Establishment Licences (DELs), while also supporting GMP audit readiness and direct Health Canada inspections for Canadian facilities.

Our Comprehensive GMP & Quality Services Include:

  • Validation Protocols & Reports
  • Manufacturing Process & Cleaning Support
  • Analytical & Laboratory Services
  • MDEL & DEL Licensing (Canada)
  • GMP Compliance & Inspection Readiness
  • Vendor Qualification & Audit Support
  • Regulatory & Quality Consulting
Our experienced consultants serve as an extension of your QA/RA teams to provide: Quality system design and implementation, Lifecycle GMP consulting for clinical to commercial stages, QMS audit remediation strategies, Support for responding to regulatory observations (e.g., Health Canada IRs, FDA 483s).
 
Propharmex has a strategic alliance with a Canadian pharmaceutical warehouse and healthcare logistics provider, offering clients a seamless one-stop shopping for all regulatory and compliance requirements