Meet Issue of the Month Author, Brian Nadel

Brian Nadel works with domestic and international clients on matters of FDA compliance and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceuticals (OTC, prescription and APIs). Mr. Nadel conducts quality based audits, mock-FDA inspections and inspection readiness audits to assess site compliance with applicable requirements and assists with FDA-483/Warning Letter remediation and responses as well as general quality system CAPAs. Mr. Nadel has been a consultant since 2012, with prior careers at both FDA and industry. Mr. Nadel was the Senior Director, US Quality & Compliance and GMPs at Sanofi-Aventis, and Senior Compliance Manager, Corporate Quality & Compliance, GMP Compliance Assessment at Forest Laboratories, Inc. Mr. Nadel also worked as a compliance officer and investigator at FDA’s Center for Drug Evaluation and Research.

Posted in 2018 January, Who’s Who at EAS.