Dossier Preparation As Per CTD Format | Regulatory Affairs | NDA | ANDA | MAA

In this lecture, we discussed how to prepare pharmaceutical dossiers as per common technical document (CTD) format for submitting various types of applications such as New drug application (NDA), Abbreviated new drug application, and marketing authorization application (MAA) to the regulatory agency.

We discussed the following:
Common technical document (CTD)
CTD Modules types
Module 1- Administrative and Prescribing Information
Module 2- CTD Summary
Module 3- Quality
Module 4- Non-clinical Study Reports
Module 5 - Clinical Study Reports

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