Module – 1
Module-1: Administrative Information and Prescribing Information
1.0 Cover Letter
1.1 Comprehensive Table of Content
1.2 Application Form
13 Pdt If ti 1.3 Product Information
1.3.1 SPC’s, Labelling and Packaging
1.3.2 Mock-Up
1.3.3 Specimen
1.3.4 Consultation with target patient group
13.5 SPC’s already approved in the Member 1.3.5 SPC s already approved in the Member states
1.3.6 Braille
Module - 2
Module - 2: CTD Summary
2.1 Table of Content (Comprehensive)
2.2 Introduction (general introduction to the pharmaceutical, including its pharmacology class, ( mode of action, and proposed clinical use)
2.3 Quality Overall Summary
2.4 Non-clinical Overview
2.5 Clinical Overview
2.6 Non-clinical Written and Tabulated Summaries
2.7 Clinical summary
Module - 4
Module - 4: Non-clinical Study Reports
4.1 Table of contents
4.2 Study Reports
4.2.1 Pharmacology
4.2.1 Primary Pharmacodynamic
4.2.2 Secondary Pharmacodynamic
4.2.3 Safety pharmacology
4.2.4 Pharmacodynamic drug interactions
Module - 3
Module – 3: Quality Qy
3.1 Table of Contents
3.2 Body of Data y
3.2.S Drug Substance
3.2.S.1 General Information
3.2.S.1.1 Nomenclature
3.2.S.1.2 Structure
3.2.S.1.3 General Properties
3.2.S.1.3 General Prope
Mdule - 5
Module - 5: Clinical Study Reports
5.1 Table of Contents
5.2 Tabular Listings of All Clinical Studies
5.3 Clinical Study Reports
5.3.1.1 Bioavailability (BA) study Reports
5.3.1.2 Comparative BA and Bioequivalence study reports5.3.1.3 In-vitro In-vivo Correlation study reports
5.3.1.4 Reports of Bioanalytical and Analytical methods
5.3.2.1 Plasma Protein Binding Study5.3.2.2 Reports of Hepatic metabolism and Drug Interaction Studies and Drug Interaction Studies
5.3.2.3 Reports of Studies Using human Biomaterials
We are Your reliable partener for eCTD file preparation
