Rajesh K. Gupta

Dr. Rajesh K. Gupta, President and Principal Consultant at Biologics Quality & Regulatory Consultants, LLC, brings over 40 years of expertise in the development, production, quality control, and regulation of vaccines and biological products. His career spans both industry and regulatory agencies, notably at the FDA's CBER, where he named the Division of Biological Standards and Quality Control, serving as Deputy Director and Lab Chief. His responsibilities included lot release of biological products, BLA review of analytical methods, including bioassays, generation of reference standards, and development of new methods. Prior to this, he held key positions at Biologics Consulting Group, Wyeth, Chiron, the Massachusetts Public Health Laboratories, and the NIH in the United States, as well as at the National Institute of Immunology and the Central Research Institute in India. Dr. Gupta's significant contributions include advancements in vaccine adjuvants and delivery systems, polysaccharide-protein conjugate vaccines, combination vaccines, and the development and validation of analytical methods, including potency tests and bioassays. He has authored over 100 publications in peer-reviewed journals and books and made numerous presentations at scientific and regulatory meetings.