Niyati Shah

Niyati Shah is the Head of Regulatory Affairs at COD Research, where they lead the regulatory affairs business unit, guiding global clients through strategies and submissions for biosimilars, novel products, and generics. With over 19 years of experience in the pharmaceutical industry, Niyati specializes in product development strategy and has successfully implemented clinical trial and lifecycle management strategies in previous roles at Intas Pharmaceuticals. They hold a Master’s degree in Bio Medical Technology from Gujarat University and are proficient in CMC Regulatory Affairs and Regulatory Strategy Development.