HomeGlobal Regulatory Simulator
Global Regulatory Simulator
Configure your regulatory submission project. Select a region and country, choose the drug type, and walk through the full dossier workflow.
Drug Type
Workflow
Master Dossier Tree
ANDA Mode
Module 1 — Administrative & Regional
1.1 Forms & Cover Letters
1.2 Table of Contents
1.3 Labeling
1.4 References
Module 2 — CTD Summaries
2.1 CTD Table of Contents
2.2 Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Summaries
2.7 Clinical Summary
Module 3 — Quality (CMC)
3.1 Table of Contents
3.2 Body of Data
3.3 Literature References
Module 4 — Nonclinical Reports
4.1 Table of Contents
4.2 Study Reports
4.3 Literature References
Module 5 — Clinical Reports
5.1 Table of Contents
5.2 Tabular Listing
5.3 Clinical Study Reports
5.4 Literature References
Documents
28 regulatory documents (Generic focus)
01Stability Study Report
02CMC — Drug Substance
03CMC — Drug Product
07Quality Overall Summary
08Bioequivalence Study Report
09Dissolution Profile Data
10Impurity Profile Analysis
11Genotoxic Impurity Assessment
12Reference Standard Certificate
13Container Closure System
14Manufacturing Process Validation
15Analytical Method Validation
27Risk Management Plan
28Pharmacovigilance System
30Environmental Risk Assessment
31Labeling / Package Insert
32Medication Guide
33Patient Information Leaflet
34Application Form (356h / M1)
35Cover Letter
36Patent Certification
37Biowaiver Justification
38Comparator Product Information
39Excipient Compatibility Study
40Elemental Impurities Report
41Residual Solvents Data
42Batch Analysis Certificate
43Post-Approval Stability Protocol