Global GMP Expertise. Localized Insight. Compliant Results.
Trusted consultancy rooted in EMA, U.S. FDA, and Health Canada GMP regulations — harmonized with ICH, PIC/S, PDA, and ISPE standards.
Regulatory Excellence Across Three Jurisdictions
Comprehensive GMP support aligned with the world’s leading regulatory frameworks.
Navigating EU GMP and Annexes with confidence.
Leverage deep expertise in EudraLex Volume 4, Annex 1, and EU-specific quality and compliance expectations. Ideal for EU-headquartered companies and international firms seeking EU market authorization.
Meeting U.S. FDA 21 CFR compliance, PAI readiness and beyond.
Support tailored to U.S. FDA expectations for both drug and biotech manufacturing, including guidance on inspections, warning letters, and quality system readiness.
GMP compliance with Canadian regulatory precision.
Expertise in Canadian GMPs and alignment with the Food and Drugs Act & Regulations. Especially relevant for companies operating in or exporting to Canada, including biotech and small-molecule manufacturers.
Areas served
-
Pharmaceutical Manufacturing
Support for small- and large-molecule drug production, from batch record reviews, inspection readiness, to regulatory submissions and GMP compliance.
-
Biotechnology
Biotech-specific QA strategies, tech transfer support, and compliance with evolving standards for ATMPs and biologics.
-
Clinical Trial Manufacturing (GMP for IMPs)
Specialized experience with GMP for investigational medicinal products (IMPs), Phase I–III production, and EU Annex 13.
-
Contract Development & Manufacturing Organizations (CDMOs)
End-to-end quality and compliance support for CDMOs operating under multiple regulatory frameworks.
How We Work — Tailored, Hands‑On, Regulator‑Ready
We bring deep GMP expertise to your team in the way that fits you best — whether it’s fractional QA leadership, project‑based QMS design, remediation sprints, or AI systems integration. We collaborate closely with your team to deliver compliant systems and confident outcomes — without long‑term overhead.
Key Services
-
From fractional QA leadership, QMS design and upgrades, to AI integration and compliance remediation, we provide flexible, high-impact support across the full spectrum of quality functions. Whether you're scaling, recovering, or transforming, our services are designed to meet you where you are.
Explore all Services.
Why work with Retzlaff Consulting?
Global Standards. Practical Solutions. Trusted Expertise.
At Retzlaff Consulting Inc., we combine deep regulatory knowledge with real-world industry insight to deliver GMP compliance that works — not just on paper, but on your shop floor, in your documentation, and at your next inspection.
Our hands-on experience spans EMA, FDA, and Health Canada frameworks, harmonized with ICH, PIC/S, and global industry standards. Having worked with EU-based global pharma, Indian manufacturers, and Canadian biotech firms, we tailor compliant solutions that align with your operations, scale, and lifecycle stage.
Value. Speed. Reliable.
Martin Lehmann, CPO of Qualifyze
“Marco’s contribution to our understanding of the market and our positioning was invaluable. He brought new perspective and practical insights which helped our business objectives.We appreciate his great energy and positive attitude during our collaboration on several thought provoking projects.”
Paul McNulty, Former U.S. Deputy Attorney General
“If you think compliance is expensive, try non-compliance.”