Dr. Marco Retzlaff

Global GMP Compliance. Practical Solutions. Scalable Quality Systems. Retzlaff Consulting Inc. is an independent consultancy specializing in GMP and GxP compliance for the pharmaceutical and biotechnology industries. We help companies worldwide — from emerging biotechs to established manufacturers and CDMOs — meet the regulatory expectations of EMA, U.S. FDA, and Health Canada. Founded by Dr. Marco Retzlaff, a global quality expert with over 15 years of experience, our mission is to bridge science, operations, and compliance through risk-based, fit-for-purpose quality strategies. What We Deliver: - GMP inspection readiness and regulatory support (EMA, FDA, Health Canada) - GxP remediation after audits, inspections, or compliance gaps - QMS and eQMS design, implementation, and validation - Quality frameworks across development, clinical, and commercial phases - Strategic QA leadership, QP/RP advisory, and fractional quality roles - Global alignment for manufacturers in India, China, Korea, and beyond exporting to regulated markets We work with pharmaceutical, biotech, and life science companies around the world who are scaling into GMP, preparing for inspections, or remediating risk — providing clarity, confidence, and regulatory success. 📍 Based in Canada — Supporting clients globally