🎓 Virtual Regulatory Affairs Lab Portal
Institution Name
🔐 Student Submission System
Step 1: Download Submission Templates
- 📄 Download eCTD XML Backbone Template
- 📑 Download Submission Summary PDF Template
- 📊 Download Lifecycle Tracking Sheet
Step 2: Upload CTD Modules
Upload your compiled CTD modules using the official submission form:
- 📁 Submit Module 1 – Administrative Information
- 📁 Submit Module 2 – CTD Summaries
- 📁 Submit Module 3 – Quality
- 📁 Submit Module 4 – Nonclinical Study Reports
- 📁 Submit Module 5 – Clinical Study Reports
Step 3: Submit Complete eCTD Sequence
- 🚀 Submit Sequence 0000 (Initial Submission)
- 🔄 Submit Sequence 0001 (Amendment)
- 🔁 Submit Sequence 0002 (Replacement)
🧩 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.
ClovisMed pharmacovigilance Consultancy 