| What it does | AI regulatory submission software that cuts 6+ weeks and $250K of rework from every submission cycle
| SOX compliance software with AI control testing
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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.
| Free trial: 14 days, $0, includes 5 AI sample tests and 50 manual tests. Starter: $99 first month, then $279/month, includes 25 AI sample tests monthly and unlimited manual testing. Professional: $799/month, includes 80 AI sample tests monthly, year-end package and external auditor package. Enterpri
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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
| - Risk and Control Matrix import
- Evidence file matching and organization
- Multi-entity control management
- Deficiency tracking and remediation
- Role-based access control
- Year-end SOX 404 reporting
- Automatic deficiency creation from exceptions
- Segregation of duties enforcement
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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
| - AI shows its work with exact quote and page citations on every verdict
- Hash-chained audit trail that auditors can verify independently
- Evidence never used to train AI models
- All steps locked and recorded from population upload to signed-off test
- Consolidates entire SOX testing workflow in one workspace instead of spreadsheets
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| Community votes | 0 | 0 |
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| DR (Domain Rating by Ahrefs) | 31 ▼ −1 (down) since last check | Not checked yet ● no change since last check |
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| Trust Flow (Majestic) | 23 | 0 |
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| Citation Flow (Majestic) | 40 | 1 |
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| Referring domains (Majestic) | 415 | 1 |
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Assyro AI
SOXLayer