2) Review Related Work • Approval reviews of new drugs and medical devices based on the Pharmaceutical Affairs Law (PAL) • Guidance and advice related to clinical trials • Reviews of GLP and GCP compliance of attached data of approval applications and reexamination and reevaluation applications • Reviews of manufacturing facilities, processes, and quality control by GMP inspections • Confirmation of reexaminations and reevaluations based on the Pharmaceutical Affairs Law
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