Yuvaraj G, MPharm, PhD, DSc Dr. Yuvaraj G is Project Director at KMC BioMed Valley City, India, and an independent drug discovery CRO–QA consultant. He is the founder and owner of CDN, providing IND support, CRAMS, CRO preclinical drug discovery services, and regulatory consultancy to the pharmaceutical industry. He has extensive experience in the design and implementation of preclinical, clinical, and commercial quality systems. He has held senior management positions across various contract research organizations and pharmaceutical companies. His areas of expertise include quality systems development and compliance audits for GLP, GCP, GMP, ISO 9001, ISO 15189, ISO 17025, and ISO 27001. He is also an expert in quality systems for computerized data, aligned with GLP, 21 CFR Part 11, GAMP, and PIC/S requirements. Dr. Yuvaraj has audited clinical studies (Phase I to Phase III) across therapeutic areas including oncology, endocrinology, respiratory, and CNS disorders, and has co...
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