Abbreviated New Drug Submission (ANDS) Software, Health Canada eCTD
Build generic drug submissions with the Canadian Module 1 and validate every sequence against Health Canada's eCTD rules. For generic manufacturers filing in-house and consultancies filing for clients.
ANDS Filing Workflow
See where generic filings lose time across drafting, review, validation, and readiness.
Write the Canadian Module 1 for Each ANDS Sequence
Assyro writes ca-regional.xml to Health Canada's Module 1 schema 2.2 with the ANDS regulatory activity type.
Stop Schema Errors Before the Build
A Module 1 that does not match the Canadian schema is stopped before the sequence is built.
Validate Against Health Canada's Rules
Each sequence is checked against Health Canada's eCTD validation rules, version 5.3.
Keep the Lifecycle in Order
Each sequence records the sequence it relates to, so the dossier's history stays readable.
ANDS Filing Controls and Capacity
Keep submission growth controlled with clearer ownership, better traceability, and consistent execution across active programs.
Maintain Audit-Ready ANDS Records
ANDS sequences are checked against Health Canada's Module 1 schema 2.2 and eCTD validation rules version 5.3, with audit trails and role-based access.
Manage More ANDS Programs With the Same Team Size
Track Health Canada correspondence and commitments in Assyro RIM
Guides for your next decision
Explore requirements, compare workflows, and prepare your evaluation.
Questions About ANDS Submission Software
Practical questions generic manufacturers and consultancies ask about Health Canada ANDS filings.
