This course explains the key documents and regulatory processes involved in clinical research and drug development. It covers Essential Documents, IND submissions, Clinical Study Reports (CSR), and New Drug Applications (NDA).

Learners will understand the roles of sponsors, investigators, and ethics committees, along with regulatory requirements under global guidelines. The course also highlights inspection readiness, compliance, and proper documentation practices.

By the end of the course, participants will have a clear understanding of how regulatory submissions support drug approval.

Indian students: Choose the Offline Payment option at Checkout. Once your Order is created you will receive an email with a link to complete your payment of INR 19,999.