Dr Tamal Raha

Tamal is the founder of Integrated Biopharma and Pharma Solution (IBPS), a scientific and technical consulting firm and has served many MNCs in India, US, Europe, Latin America and China. He also serves as a mentor for the bio-incubator centre of Indian Institute of Technology Kanpur.

Tamal has rich experience in biopharmaceutical development and regulatory strategy having undertaken extensive work in Biologics and Biosimilar product development, process development (CMC), non-clinical and clinical development strategy, comparability studies, technology transfer, global regulatory, CTD modules and analytical characterization.

He has experience in running successful clinical trials (Phase I to Phase IV) in different geographies with multiple partners. He has led product registration in EU, South Asia, South East Asia, MENA, Latin America, Brazil and Mexico. Tamal was instrumental in helping the National regulatory authority in India (CDSCO) and South Africa in drafting biosimilar guidelines.

Tamal served as Head of product development of Cipla Biotec Pvt. Ltd., Director and Head of Biotech Regulatory Affairs and R&D for Chemo (Mabxience) based out of Madrid, Spain, Director of Regulatory affairs at Dr. Reddy's Laboratories, and a lead scientist in drug development at INTAS Pharmaceuticals.