SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Guirag Poochikian, Ph.D.
Chemistry, Manufacturing, and Controls; Drug Development and Implementation; Inhalation Drug Products; Combination Products; Stability Protocols; Quality Systems and Compliance
Guirag Poochikian is the former FDA Associate Director for Regulatory Science and Policy, Office of New Drug Quality Assessment, CDER. He has more than 25 years of regulatory science experience at FDA, which includes oral inhalation and nasal inhalation drug products among other dosage forms, pharmaceutical cGMPs, development of Agency CMC guidances and policies, and participation on counterfeit drug and drug quality task forces. He is experienced working in scientific cross-discipline teams and was involved in the recent FDA Quality initiatives. He assists pharmaceutical manufacturers in designing research and development programs, addressing CMC documentation issues for Agency review (e.g., INDs, NDAs, Supplemental drug applications), complying with cGMPs, preparing for FDA meetings, evaluating drug substances and excipients in drug products, and developing and evaluating stability protocols.
