Jaymeth E. Maddox, RAC

Areas of Expertise:

Jaymeth Maddox, RAC

Jaymeth provides regulatory, CMC, and compliance support to companies developing drugs, biologics, devices, and combination products, including complex products such as modified-release, inhalation, human blood- and plasma-derived, injectable, and topical products in the pre- and postmarketing phases of development. He has assisted in the certification management of contract of new manufacturing facilities organization; managed conduct and close-out of investigations for the identification and qualification of impurities and/or excipients; and overseen the operational and regulatory filing aspects for changes to manufacturing processes, product control strategies, analytical procedures, shelf-life extensions, and container closure systems. Jaymeth is also experienced in managing stability programs. He has led Quality Management System and cGMP compliance audits and reviews of drug, biologic, and radiochemical manufacturing facilities, including those that specialize in solid oral dosage form, liquid dosage forms, inhalation products, lyophilization, aseptic manufacturing, human blood- and plasma-derived products, vaccines, and radiological processing. Jaymeth has a B.S. Biochemistry with a minor in Chemistry from the Virginia Polytechnic Institute and State University (Virginia Tech). He maintains Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).