Punam Borate

With over 13 years of experience in regulatory affairs, I am currently an Assistant manager in the International Regulatory Affairs Department at Serum Institute of India. My work focuses on developing regulatory strategies for new product development, ensuring compliance with global guidelines like ICH-CTD and e-CTD, and managing end-to-end submission processes in close coordination with cross-functional teams. My expertise includes reviewing technical documents, preparing dossiers, addressing health authority queries, and maintaining global registration statuses, particularly for biological products. I am committed to fostering collaboration across departments while supporting marketing and logistics teams, ensuring compliance, and delivering effective solutions to regulatory challenges.