Marketing Authorization Application (MAA) Software, EMA eCTD
Build the centralised MAA with the EU Module 1 and validate every sequence against the EU eCTD criteria. For sponsors filing in-house and consultancies filing for clients.
MAA Filing Workflow
See where MAAs 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 with maa as the submission type.
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 in v4.0 With the Limits Shown
Assyro builds the initial v4.0 MAA sequence and shows what it cannot build yet before you choose v4.0.
Correspondence and Commitments in One Place
Track EMA questions, responses, and commitments in Assyro RIM next to the submission.
MAA Filing Controls and Capacity
Keep submission growth controlled with clearer ownership, better traceability, and consistent execution across active programs.
Maintain Audit-Ready MAA Records
MAA 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 MAA Programs With the Same Team Size
Track EMA correspondence and commitments in Assyro RIM
Guides for your next decision
Explore requirements, compare workflows, and prepare your evaluation.
Questions About MAA Submission Software
Practical questions sponsors and consultancies ask about EMA MAAs.
