eCTD Software That Cuts 6+ Weeks and $250K of Rework
AI eCTD submission software for pharma, biotech, and regulatory operations teams. Draft faster, validate earlier, prevent late sequence defects, and keep every submission audit-ready in one workspace.
Reclaim 100+ Hours Per eCTD Submission Cycle
Submission teams lose time to rework, version drift, late validation findings, and manual readiness reporting. Assyro reduces each one inside a single eCTD workflow.
Cut eCTD Review Cycles From Weeks to Days
Authors, RA, RegOps, QA, CMC, and publishing review against the same controlled sequence state with shared owners, comments, and traceability. Late-stage review loops stop turning into deadline scrambles.
Prevent $250K of Rework Before Publishing Lock
Assyro runs structural, lifecycle, hyperlink, metadata, bookmark, PDF, and readiness checks while content is still being drafted. Defects route to the owner who can fix them before publishing inherits the cleanup.
Track eCTD Readiness in Real Time
A live readiness view combines validation findings, authoring progress, template coverage, lifecycle conflicts, and owner status. Teams know what blocks the next sequence before the filing window closes.
Run Deadline-Driven eCTD Workflows Automatically
Validation, template checks, owner routing, publishing readiness, and lifecycle review trigger at T-30, T-14, and T-3. Critical sequence checks live in the workflow instead of scattered reminders.
Scale eCTD Submission Capacity Without Expanding Headcount
Give lean regulatory teams more capacity with repeatable templates, continuous validation, lifecycle controls, and audit-ready execution across active eCTD programs.
Stay Audit-Ready While Reducing Rework
ICH eCTD, FDA eCTD Technical Conformance Guide, 21 CFR Part 11 aligned workflows with audit trails, role-based access, and submission traceability.
Coordinate More eCTD Programs With the Same Team
Scale more eCTD programs with the same team by standardizing templates, validation, lifecycle history, and publishing readiness
Questions Regulatory Leaders Ask Before Buying eCTD Software
Straight answers about eCTD readiness, rework reduction, rollout scope, validation, publishing, and expected impact.
