EMA eCTD Submissions, Checked Before You File
Build the EU Module 1 for the centralised procedure and validate every sequence against the EU eCTD criteria. Catch technical defects in the workspace where the content was written, not after you file.
EMA Filing Workflow
See where EU submissions lose time across drafting, review, validation, and readiness.
Build the EU Module 1 for the Centralised Procedure
Assyro writes eu-regional.xml to EU Module 1 specification 3.1.1 from what the filing records.
Validate v3.2.2 Against EU Criteria 8.2
Each v3.2.2 sequence is checked against the EU eCTD Validation Criteria, version 8.2.
Start v4.0 Applications With the Limits Shown
Assyro builds the initial v4.0 MAA sequence and shows what it cannot build yet before you choose v4.0.
Run the EU Next to FDA and Health Canada
EU submissions sit in the same workspace as your FDA and Health Canada work, with clear owners.
EMA Filing Controls and Capacity
Keep submission growth controlled with clearer ownership, better traceability, and consistent execution across active programs.
Maintain Audit-Ready EMA Records
Sequences are checked against the EU eCTD Validation Criteria (v8.2 for v3.2.2, v1.1 for v4.0), with audit trails and role-based access.
Manage More EMA Programs With the Same Team Size
Keep EU, FDA, and Health Canada submissions in one workspace with clear owners
Guides for your next decision
Explore requirements, compare workflows, and prepare your evaluation.
Questions About EMA Submission Software
Practical questions buyers ask about EMA eCTD submissions.
