DurgaprasadSeeram.

Director / Senior Consultant

A highly accomplished pharmaceutical professional with over 40 years of expertise in quality assurance, regulatory compliance, and responsible sourcing. He has a proven track record in leading GMP audits, ensuring CGMP compliance, developing quality management systems, and contributing to pharmaceutical research and development. His career is distinguished by numerous awards and recognitions, including FIC (Fellow of Institution of Chemists), CC (Chartered Chemist), PhD in Chemistry, CChem (Chartered Chemist), CSci (Chartered Scientist), and FRSC (Fellow of the Royal Society of Chemistry). His work experience includes several renowned pharmaceutical companies, such as Pfizer, Mylan, Armadale Consultancy, and NorthStar (a McKesson Fortune 10 US company). With over 20 years of experience as a lead auditor, he has conducted several hundred on-site CMO/API supplier CGMP compliance, Responsible Sourcing (Social Accountability/Supplier Sustainability) and Pharmacovigilance audits worldwide. His expertise covers a wide range of audit standards, including 21 CFR Parts 210/211/600/820, EU Directives & GMP, MHRA, WHO, TGA, ICH, Schedule M, ISO 15378, ISO 9000, ISO 13485, SA-8000 and GVP. Throughout his career, he has published extensive research on pharmaceutical product development and analytical method development. He is a recognized technical expert in various dosage forms, including sterile products, and has contributed to biological and biotech greenfield projects.