Saurabh Upadhya, M.Sc., Senior Regulatory Affairs Consultant
Regulatory Affairs professional, with broad expertise in diverse organisations, including pharmaceutical MNCs, start-ups, Regulatory Consultancies, and Clinical Research Organizations (CROs). Currently responsible for managing the regulatory submissions process for drugs across various therapeutic areas to the Food and Drug Administration (FDA) and Health Canada.
With a keen eye for detail and a commitment to compliance, I have successfully prepared and submitted IND/CTA, NDA/NDS, and BLA submissions to the FDA and Health Canada. I am also experienced in regulatory compliance and post-market surveillance, ensuring that all drugs meet regulatory requirements throughout their lifecycle.