About Retzlaff Consulting Inc.

Founded by Dr. Marco Retzlaff, Retzlaff Consulting Inc. brings over 15 years of international experience in pharmaceutical and biotech quality assurance. Marco has led GMP and quality initiatives across Europe and North America — from global generics and biosimilars to cutting-edge biologics and clinical-stage startups.

His leadership has included:

• Serving as Head of QA Operations for Novartis/Sandoz Germany, overseeing 1,500+ products

• Leading an EU QP Release Hub and acting as Wholesaler Responsible Person and Narcotics Officer

• Building the CMC/GMP framework for a new biotech facility in Canada, including building a Development QA team and a validated QMS infrastructure

• Mastering regulatory inspections by FDA, EMA, Health Canada, Swissmedic, AGES, ANVISA, The Russian Health Authorities, and others

• Ensuring network-wide product realization for Sandoz development products as Global Development QA Manager

• Driving remediation and inspection readiness for global sites, often under tight timelines and complex conditions

With a PhD in Biotechnology, certified Lean Six Sigma Green Belt, and experience as a trained European patent attorney, Marco brings a rare blend of scientific depth, regulatory insight, and strategic business alignment.

At the heart of his approach is a commitment to cultivating quality culture — empowering teams, not just systems, to succeed.