| Key features | - Connect and sync source documents across SharePoint, Box, Google Drive, and other systems
- Real-time submission readiness tracking combining validation findings, drafting progress, and risk signals
- Automated deadline-driven workflows with validation, drafting, routing, and readiness checks at T-30, T-14, and T-3
- 21 CFR Part 11 and EU Annex 11 compliant audit trails with role-based access
- eCTD structure, lifecycle, and metadata validation before submission
- eSTAR completeness, evidence packaging, and filing readiness validation for medical devices
- Multi-jurisdiction coordination with FDA, EMA, and Health Canada workflow support
- Sponsor isolation controls for CROs with separate document storage, access controls, and audit trails per sponsor
- Sponsor read-only dashboard for real-time program status and readiness scoring
- Repeatable workflows and pre-configured templates for rapid sponsor onboarding
| - Cryptographically chained audit logs for every AI interaction
- Multi-framework compliance mapping (EU AI Act, DORA, BaFin, FINMA, DSGVO, NIS2)
- Verifiable PDF and JSON reports with SHA-256 hashes
- Public verification of reports without platform access
- Air-gap and on-premise deployment options
- Single API integration with no infrastructure changes required
- 10-year audit log retention
- EU data residency with Hetzner infrastructure
- Support for 6 AI provider models
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| What makes it different | - Recovers 100+ hours and avoids $150-250K in rework and filing delay costs per submission
- Reduces eCTD and eSTAR defects before filing through continuous validation during drafting
- Eliminates version drift and manual status reporting with shared comments and real-time traceability
- Standardizes CRO workflows across multiple sponsors without per-sponsor customization
- Enables lean teams to handle 3x more submission capacity without expanding headcount
| - Deterministic, rule-based classification eliminates AI interpretation bias
- Cryptographically verifiable reports require no witness or platform access
- Single integration covers all major EU regulatory frameworks simultaneously
- Customer data never leaves customer infrastructure; only hashes sent to Vereefy
- Onboarding completed in 1–5 business days
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Assyro AI