Registration for Fall 2026 programs and courses is now open. Learn more about the academic programs we are delivering in Fall 2026. If you have any questions about part-time studies, please contact us.
Prerequisites:
This course focuses on the preparation of a drug submission. Students compile the necessary information and complete the necessary application forms for a Common Technical Document (CTD) New Drug Submission (NDS) Module 1 along with the overall plan for the compilation of a submission. There is a class presentation relating to policy application for submissions with possible practical application and possible suggestions for dealing with expected deficiency. Introduction to auditing and the Preapproval Inspection (PAI) for submission approval are discussed and an audit practical exercise performed.
Ancillary fees will be added at checkout and will vary based on the number of courses selected. For details on how the fees are calculated, please refer to ancillary fees for part-time studies.