🎓 Virtual Regulatory Affairs Lab Portal

Institution Name

🔐 Student Submission System

Step 1: Download Submission Templates

Step 2: Upload CTD Modules

Upload your compiled CTD modules using the official submission form:

Step 3: Submit Complete eCTD Sequence

🧩 ICH eCTD Structure (Reference)

/ectd
 ├── m1
 │   ├── 1-0-cover-letter.pdf
 │   ├── 1-2-forms.pdf
 │   └── 1-3-labeling.pdf
 ├── m2
 │   ├── 2-3-quality-overall-summary.pdf
 │   └── 2-5-clinical-overview.pdf
 ├── m3
 │   ├── 3-2-s-drug-substance.pdf
 │   └── 3-2-p-drug-product.pdf
 ├── m4
 │   └── nonclinical-study-reports.pdf
 ├── m5
 │   └── clinical-study-reports.pdf
 └── index.xml

📊 Faculty Dashboard (Front-End View)

📈 Submission Analytics

Total Submissions: ____
Batch A: ____
Batch B: ____
Batch C: ____

📥 Faculty Actions

🧪 Built-in Validation Rules (Academic Simulation)

Sequence 0000 must use lifecycle: New
Subsequent sequences must use lifecycle: Replace / Append
Module 1 is mandatory
XML backbone must include application number

🌍 Multi-Batch Classroom Support

Batch A – Regulatory Affairs 2026
Batch B – Pharmaceutical Quality 2026
Batch C – Clinical Research 2026

📦 eCTD Lifecycle Simulation

0000 – Initial Submission
0001 – Response to Query
0002 – Labeling Update
0003 – Annual Report

🏆 Academic Use Only – Training Simulation Portal

This portal is designed for educational demonstration of ICH eCTD submission workflow.