NDA & Supplemental Drug Application Regulations in Pharma
Suresh Kankanwadi
About Me
Drug Development expert with over three decades of global experience across India, the UK, and Switzerland, specializing in NCEs, biosimilars, and pharmacovigilance. An MBBS, MD (Pharmacology), and PhD (Pharmaceutical Medicine) by qualification, he has led R&D, built high-performing teams, and pioneered the pharma services space in India. An ILM Level 7 certified coach and lifelong student of Indian philosophy, he is passionate about enabling personal and organizational effectiveness through coaching, mentoring, and holistic process design.Courses by me
Participants will be able to Plan and prepare compliant new and supplemental drug applications, reduce approval delays by aligning submissions with regulatory expectations, manage post-approval changes with minimal regulatory risk, and respond effectively to regulatory questions and review findings.