Terrance Ocheltree has 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 taken action for INDs, NDAs, and sNDAs. He leads multi-functional teams and interfaces with regulatory agencies, pharmaceutical industry and medical practitioners. Terrance develops, writes and edits regulatory guidance and whitepapers - Champion of 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, Guidance, Regulation, GMP, Meeting, Submission, NDA, IND, BLA, MAA. Marketing Application, New Drug Application, Combination Products, Due Diligence, Inspection, Investigation, Pharma, Bio, Biologic.