Kevin Nolan

Kevin has over 30 years of domestic and international Quality Control and Regulatory Affairs leadership experience in the pharmaceutical, biological defense, healthcare and medical device industries. He has successfully launched and licensed recombinant biologics, solid oral dosage forms as well as, parenteral and semi-solid products for the US and ROW markets.

Work experience

Kevin’s industry experience includes development and validation of analytical methodologies, and immunoassays for large and small molecule entities. He has established both domestic and foreign QC laboratories for the analytical and microbiological testing of in-process and final product stability and release testing activities.

He has planned, developed and led construction of multiple QC laboratories in support of aseptic operations, process validation and licensure of small molecules, sterile semi-solids and solid-dose drug product manufacturing facilities.

Kevin has regulatory preparation and submission of CTD submissions for the FDA on behalf of client partners and the DoD. His knowledge of CGMPs has provided expertise leading and participating in multiple USFDA Consent Decree injunctions for cytotoxic aseptic drug products and 503B compounding manufacturers.

Kevin has expert knowledge of USP, PDA Technical Reports, ICH Guidelines, ISO, FD&C Act, 21 CFR 210, 211, 601, 820 and other FDA regulations.

Education

Kevin holds a B.S. in Biology from Stonehill College