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CMC, IND, NDA, BLA, IMPD, Quality, Audit, Inspection, Qualification, Validation, CMO, CRO, FDA, EMA, MMA, Deviation, CAPA, Root Cause, SOP, Process, Development, Analytical, Method, HPLC, NMR, Formulation, Purification, Synthesis, Fermentation, Cell Culture, Chromatography, Filtration, Virus, Vaccine, Cell Therapy, Advanced Therapy, Cell Selection, Cell Expansion, Cell Transplant, Chimera, Gene Therapy, Quality Management System, QMS, Regulatory, Manufacturing, Testing, Release, Contracting, Management