Dr. B. Manivannan [PhD, M Phil, M Sc] has more than 30 years of overall experience as a leader with knowledge of international standards and regulations for the Pharma and Biotech industry. (RandD /QA /QC /RA) with technical capabilities on strategies and regulatory requirements for Lab to Launch product deliverables of pharma and biotech products with specialization for vaccines and biosimilars; Guidance on cGMP, cGLP, GCP, cGDP, CTDs and CMC, IND submission; Audit and CAPA requirements.