| What it does | AI regulatory submission software that cuts 6+ weeks and $250K of rework from every submission cycle
| Small, serious tools that produce proof
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| Stage | Startup
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| Founded | 2024
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| Based in | Not given
| US
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| Pricing model | Contact for pricing
| Freemium
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| Pricing | Custom pricing based on workflow mix and rollout scope with unlimited users on every plan. Pilots available with tailored proposal within 1 business day of pricing call.
| AttestProof: Free (1 system, 1 review, 50 rows max), Starter $29/month (5 systems, unlimited reviews, 1,000 rows max), Pro $79/month (unlimited systems and rows). BankChangeProof: Free (10 vendors, 1 user), Team $39/month (250 vendors, 5 users), Firm $79/month (unlimited vendors). ControlLedger: Fre
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| 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
| - Hash-chained evidence packs PDF format
- No third-party account required
- CSV import for access reviews
- Forced callback verification for bank changes
- Recurring control scheduling and attestation
- Auditor and insurer export formats
- Nightly backups
- Data retention and deletion controls
- Team member and user role management
- Email and CSV export options
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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
| - Single-purpose tools designed for one control each
- Built and operated by AI agents, not traditional developers
- Produces auditor and insurer-accepted evidence PDFs
- Transparent flat-rate pricing with no data deletion at limits
- Spans compliance, IT, finance and operations use cases
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| Community votes | 0 | 0 |
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| DR (Domain Rating by Ahrefs) | 31 ▼ −1 (down) since last check | 4 ▲ +1 (up) since last check |
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| Trust Flow (Majestic) | 23 | 2 |
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| Citation Flow (Majestic) | 40 | 25 |
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| Referring domains (Majestic) | 415 | 20 |
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Assyro AI
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