| 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
| - SDS Indexing: extract data from supplier PDFs into structured data with confidence scores
- GHS classification with deterministic rules engine applying additivity formulas and bridging principles
- SDS authoring in over 25 languages from curated phrase library
- GHS label generation from classified data
- Transport and DOT classification
- Regulatory monitoring across OSHA, EPA, REACH, CLP and other sources
- API access to all product data fields
- Support for US, Canada, Mexico, EU, UK, and UN module regulations
- Data enrichment from database of over 60,000 CAS numbers
- Full audit trail for every classification and SDS step
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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 rules engine ensures consistent, auditable classifications instead of probabilistic AI models
- Implementation in weeks using AI extraction of existing SDSs, not manual re-entry
- Customer data never used to train AI models; formulations remain private and isolated
- Open API with free data export; no lock-in or fees to leave
- Automatic regulatory change monitoring flags affected SDSs for review
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Assyro AI
Valenc