Sunil Chandane

Background

About Sunil Chandane

I'm an experienced Regulatory Affairs professional with over 9 years of expertise in Sugam applications like New Drug, SND, FDC, Clinical Trials, BA/BE Study, Test licence, Manufacturing & Marketing, Import Registration and Medical Devices. I've handled State FDA applications (Form 25-A, Form 28-A, COPP, Wholesale licence renewal & PAC) and assisted Tender teams with diverse applications like IMC, NCC, MSC, SIC and more. Additionally, I have extensive experience in monitoring BE studies, developing packaging inserts, reviewing label artworks, promotional materials and ensuring compliance with FSS regulations for food product labeling. I am well-versed in regulatory frameworks, including the D&C Act, MDR 2017 and the FSS Act, along with their associated regulations.