Mr. Brian Nadel

Brian Nadel is currently President of Brian G. Nadel GMP Consulting, LLC. Mr. Nadel provides independent CGMP Consulting Services for pharmaceutical and API manufacturers. He provides his broad-based knowledge in quality assurance, compliance, gov’t/regulatory agency requirements, and experience in pharmaceutical and Consent Decree environments.

Mr. Nadel was previously a Senior Consultant at PAREXEL International. He has over 25 years of diverse experience in Pharmaceutical Quality Assurance and Quality Systems, Pre-Approval Inspections, International CGMP auditing for finished products, Active Pharmaceutical Ingredients, Fermentation, Chemical Synthesis, Process Validation and Botanical Extraction and Purification.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP Compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and Compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for Sanofi. Before that he was a Senior Manager in Forest Laboratories where he held the position of Pre-Approval Inspection Manager in the R & D Quality assurance department. He started his career as an Investigator for the US FDA as a Drug Specialist in the New York City area. He was then promoted to the FDA’s Center for Drug Evaluation and research (CDER) in Rockville, MD, where he served as a Compliance office in the office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees and Injunctions.

Mr. Nadel holds a BA in Biology from SUNY at Albany, Ny and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association (PDA). Mr. Nadel has spoken at several industry forums.