Core Capabilities for Submission-Ready Execution

Monitor FDA, EMA, ICH, and Health Canada updates in one workflow and map each change to the documents, owners, and timelines it affects.

Draft structured regulatory documents with linked citations, tracked revisions, and shared review workflows that keep teams aligned.

Connect scientific narratives, regulatory language, and evidence traceability in one workspace for review-ready medical writing.

Assyro is eCTD software for pharma, biotech, and regulatory operations teams that need to recover submission time, prevent late sequence defects, and keep every eCTD filing audit-ready.

Assyro is an eCTD viewer for regulatory teams that need to review sequences faster, inspect lifecycle changes, catch handoff issues, and keep package QA connected to remediation.

Assyro gives regulatory teams pre-made, ready-to-use eCTD templates for real submissions, with controlled module structure, required sections, metadata, owners, and publishing expectations already in place.

Validate upstream so structural and lifecycle defects are caught before they reach the publishing step.

Validate sequences continuously against eCTD rules as your team works, so filing issues are caught before submission lock.

Compare predicates, indications, technological characteristics, and evidence in one workflow before weak substantial-equivalence logic creates avoidable rework.

Build eSTAR-ready 510(k) and De Novo submission packages in one workflow instead of stitching forms, evidence tables, and reviews together manually.

Check eSTAR packages continuously for completeness, evidence gaps, and filing blockers before late-stage fixes push your device submission out.

Keep every sequence operation, amendment, and decision in one auditable timeline instead of reconstructing rationale from scattered emails and spreadsheets.

Scan for missing content, control gaps, and workflow blockers continuously so teams can remediate earlier in the submission cycle.

A regulatory document management system (DMS) purpose-built for submissions: version control, audit trails, and e-signatures that keep every controlled document linked to the eCTD section it belongs to.

Regulatory information management (RIM) software that tracks every product registration, submission, variation, and health-authority commitment across regions in one connected source of truth.

Regulatory submission software that plans, tracks, and manages every submission and sequence across products and regions, so deadlines, owners, and status stay visible from kickoff to filing.

Regulatory archiving software that preserves every submission, sequence, and document in a compliant, searchable long-term archive, retrievable on demand for audits, inspections, and follow-up filings.