CHANDRIKA SAMIR PATEL | Vice President - Global Regulatory Affairs
Kashiv BioSciences LLC.

Chandrika Patel is Vice President, Regulatory Affairs at Kashiv BioSciences LLC, USA with extensive experience in global biologics and biosimilar development. She leads worldwide regulatory strategies across FDA, EMA, MHRA, PMDA, and other health authorities, supporting products from early development through commercialization. Her expertise includes biosimilar regulatory pathways, BLA, NDA and IND submissions, lifecycle management, regulatory intelligence, and global market expansion. A strong advocate for digital transformation, she actively explores the application of artificial intelligence and data-driven decision-making in regulatory science. Chandrika is passionate about advancing innovative regulatory approaches that facilitate faster access to high-quality biologic medicines worldwide. Her insights combine scientific rigor, practical regulatory experience, and a forward-looking perspective on the future of healthcare innovation
She holds an M.Pharm. (master's degree) in Pharmaceutical Technology, a Post Graduate Diploma in Management (Project Management), along with professional certifications in clinical research and clinical trial management.