● EMA Regulatory Automation
eCTD Submission System
Electronic Common Technical Document — EMA Gateway Integration
A complete end-to-end automation platform for submitting pharmaceutical dossiers to the European Medicines Agency via the official AS2 gateway — covering dossier assembly, XML validation, checksum generation, and delivery tracking.
How It Works
Submission Pipeline
Dossier Assembly
Build folder structure per ICH eCTD spec with correct module hierarchy
XML Generation
Auto-generate index.xml, eu-regional.xml and delivery XML
Validation
Schema validation, PDF 1.4 compliance, ICH file naming rules
MD5 Checksums
Generate and embed MD5 hashes for all dossier files
AS2 Delivery
Transmit signed package to EMA with MDN acknowledgement
Architecture
System Components
Transport Layer
AS2 Gateway
Configured AS2 trading partner setup with EMA, including certificate exchange, routing IDs, and signed/encrypted message delivery with MDN receipt handling.
Document Layer
XML Engine
Automated generation of all required eCTD XML files — delivery XML, eu-regional.xml, and index.xml — with full schema validation against EMA DTD specifications.
Integrity Layer
Checksum & Validation
MD5 hash generation for every file, PDF 1.4 compliance checking, ICH file naming convention enforcement, and pre-submission validation reports.
Data Layer
Odoo eCTD Module
Custom Odoo models managing dossiers, sequences, context-of-use headings, documents, and submission lifecycle operations integrated with Odoo 19.
Regulatory Layer
AMP Registry
Authorized Medicinal Product registry with active ingredients, dosage forms, regulatory calendar lines, and EDA MOU markets across 11 African countries.
Tracking Layer
AS2 Message Log
Full audit trail of all AS2 messages sent and received, with delivery status tracking, error handling, and retry logic for failed transmissions.
Built With
Tech Stack
Want to know more?
Learn about the engineer behind this system and other projects in pharma, AI, and fintech.
Meet Ahmed Gamal →