Rajesh K. Gupta, PhD Biologics Quality & Regulatory Consultants, LLC

Rajesh K. Gupta has a Ph.D. in microbiology and is President and Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 40 years’ experience in the pharmaceutical microbiology, specifically in the development, production, testing, and regulation of vaccines and other biological products, working at both the regulatory agencies and the industry. At FDA, CBER, he formed the Division of Biological Standards and Quality Control and was a Deputy Director and Lab Chief in that Division, managing lot release of biological products, review of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods. In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH) in the US and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development/validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and made numerous presentations at scientific and regulatory meetings.