Nirav Patel

Nirav Patel is a seasoned Research Manager at Sun Pharma since April 2015, specializing in the preparation and submission of Abbreviated New Drug Applications (ANDAs) and managing CMC components of marketing authorization applications for various regulatory authorities including the US FDA and EU. Responsibilities include handling information requests, lifecycle management activities, and responding to regulatory deficiencies, alongside ensuring compliance with guidance and internal procedures. Prior experience includes roles as a Research Associate at Ranbaxy and Mylan Laboratories Limited, and an internship focused on developing analytical methods and dissolution media. Nirav Patel holds an M.Pharmacy degree from Birla Institute of Technology and Science, Pilani, and a Bachelor of Pharmacy from Anand Pharmacy College, Gujarat.