Area of Expertise:
Guirag Poochikian, PhD
Guirag is the former FDA Associate Director for Regulatory Science and Policy, Office of New Drug Quality Assessment. He has more than 25 years of regulatory science experience at FDA, which includes regulating oral inhalation and nasal inhalation drug products; assessing compliance with pharmaceutical cGMPs; developing CMC Agency guidances; and participating on counterfeit drug and drug quality task forces. He assists pharmaceutical manufacturers in designing research and development efforts, addressing CMC documentation issues for Agency review, complying with cGMPs, preparing for FDA meetings, evaluating excipients in drug products, and formulating inhalation products. Guirag is particularly expert in the development of inhalation drug products, including inhalation aerosols, dry powder inhalers, nasal preparations, and a variety of other dosage forms. During his tenure at FDA, Guirag also served as a Supervisory Chemist in the Division of Oncology and Pulmonary Drug Products and Pulmonary and Allergy Drug Products, a Supervisory Chemist in the Division of Surgical Dental Drug Products, and a Review Chemist in the Division of Oncology and Radiopharmaceutical Drug Products. He has a Ph.D. in Medicinal Chemistry from The Ohio State University and a B.S. in Pharmacy from the American University of Beirut, Lebanon.