Areas of Expertise:
Jaymeth provides regulatory, CMC, and compliance support to companies developing drugs, biologics, devices, and combination products, including complex products such as modified-release dosage forms, inhalation, cellular/gene therapies, human-/animal-derived product, sterile dosage forms, and topical products in the pre- and postmarketing phases of development. He has developed, executed, and managed CMC operational and regulatory filing strategies to support changes to manufacturing facilities, manufacturing processes, product control strategies, analytical procedures, shelf-life extensions, and container closure systems; identified and selected contract manufacturing facilities and managed technology transfer activities to them; and overseen investigations for the identification and qualification of impurities and/or excipients. Jaymeth has also led cGMP compliance audits (e.g., vendor qualification, vendor selection, mock-regulatory authority inspections) of manufacturing facilities and sponsors, including those that specialize in active pharmaceutical ingredients, oral dosage forms, liquid dosage forms, lyophilization/spray drying, sterilization and aseptic processing, animal-/human-derived products, vaccines, and radiological processing. Jaymeth has a B.S. in Biochemistry with a minor in Chemistry from the Virginia Polytechnic Institute and State University.