Nadine M. Ritter, Ph.D.
President and Analytical Advisor, Global Biotech Experts
Global Biotech Experts provides expert guidance and practical training in CMC analytical elements of biologic products (inc. biosimilars and CGT), and laboratory quality practices around the world. Throughout Dr. Ritter’s career, she have contributed to the success of over twenty 510(k)/PMA, ninety IND/IMPD and thirty eight BLA/MAA filings around the world. On the compliance side, she has engaged in numerous international PAI readiness audits, GMP remediations, and due diligence inspections. In these projects, she has helped address a wide array of regulatory dossier requests for information, and successfully remediated laboratory compliance citations and method performance issues. In 2003, she was a co-founder of the CaSSS CMC Strategy Forums, which has since lead to the publication of major industry/regulatory white papers on international CMC topics for biopharmaceutical products. She is actively engaged in several leading professional scientific organizations and task forces, and assists in organizing conferences to share knowledge across the field.