AI-Native Compliance for Life Science Teams. Submit 12x Faster and Stay Audit-Ready
From the first regulatory question to the final submission, all in one place. Built for FDA, EMA, Health Canada and beyond, with your expert approving every decision.
Reclaim 100+ Hours Per Submission Cycle
Regulatory teams lose time to rework, version drift, and manual status reporting. Assyro reduces each one inside a single submission workflow.
Cut Review Cycles From Weeks to Days
Regulatory, quality, and submission teams review against the same version with shared comments, owners, and traceability. Late-stage review loops stop turning into deadline scrambles.
Keep Source Documents Synced Across Systems
Connect SharePoint, Box, Google Drive, and the systems your teams already use. Assyro keeps version history aligned and reduces handoff errors before validation and final assembly.
Track Submission Readiness in Real Time
One live view combines validation findings, drafting progress, and risk signals. Teams know what to fix next and leaders get a more defensible filing timeline.
Run Deadline-Driven Workflows Automatically
Validation, drafting, routing, and readiness checks trigger automatically at T-30, T-14, and T-3. Critical timeline checks live in the workflow instead of scattered reminders.
Scale Submission Capacity Without Expanding Headcount
Give lean regulatory teams more capacity with repeatable workflows, validation controls, and audit-ready execution across active programs.
Stay Audit-Ready Across Every Submission Cycle
21 CFR Part 11, GxP, and EU Annex 11 aligned workflows with role-based access, traceable decisions, and linked submission evidence.
Coordinate More Programs Across Jurisdictions
Shared workflows, jurisdiction-specific views, and consistent execution across affiliates and partners let teams scale without rebuilding the process for each filing.
Questions Regulatory Leaders Ask Before Buying Submission Software
Straight answers about workflow fit, submission readiness, rollout scope, and expected impact.
