Kevin Nolan

Kevin has over 25 years of domestic and international experience in Regulatory Affairs, Quality Assurance, Quality Control Microbiology and Analytical departments for the pharmaceutical, biological defense, healthcare, and medical device industries. He has supported and collaborated on the successful launch and licensure of biological, solid dosage and sterile injectable and semi-solid drug products to the US and ROW markets.

Work experience

Kevin has experience with the Biological Defense Vaccine Program (BARDA) in regulatory affairs and has previously helped in the development and implementation of Environmental Microbiology testing program within vaccine and bulk drug product manufacturing facilities. He also has expertise in aseptic drug product remediation and consent decree, bulk drug substance, aseptic drug product and oral product manufacturing and quality control analysis, national vaccine stockpile assessment risk analysis against biological agents for DoD and IB writing for DoD emergency clinical use protocols.

Other experience includes CMC, Pre-Approval and GMP Inspections, laboratory testing compliance, commercial product support, including OOS Investigations, Deviations, and CAPAs. He is well-versed in 503B Pharmacy Compounding Compliance and IND/ICH CTD CMC submissions.

Education

Kevin holds a BS in Biology at the Stonehill College, Easton, Massachusetts.