Terry Ocheltree possesses diverse global pharmaceutical experience in regulatory affairs, product development, manufacturing, project management and pharmacy practice. He is a motivated leader that effectively manages and resolves complex regulatory and technical issues. Dr. Ocheltree has extensive knowledge in chemistry, manufacturing and controls (CMC) requirements, ranging from drug development through product life cycle management. He has reviewed and acted on INDs, NDAs, and sNDAs. He serves as a regulatory consultant, leads multi-functional teams and interfaces with regulatory agencies. Terry authored regulatory guidances and participates in the development of whitepapers – including championing Product Lifecycle Management, Global Harmonization/Convergence, Quality by Design (QbD), Process Analytical Technology (PAT) and Real Time Release Testing (RTRT).
Dr. Ocheltree’s expertise includes: Regulatory, CMC, Strategy, FDA, EMA, Regulation, GMP, Meetings, Submission, NDA, IND, BLA, MAA, Combination Products, Due Diligence, Inspection, Investigation, Pharma, Bio, Botanical.