| What it does | AI regulatory submission software that cuts 6+ weeks and $250K of rework from every submission cycle
| Security and compliance platform where teams define their own controls and connect policies and evidence
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| Stage | Startup
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| Founded | 2024
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| Based in | Not given
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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.
| Compliance Module: $450/month or $5,000/year. Trust Center: $300/month or $3,000/year. Trust Center attribution removal add-on: $25/month. Workflow automation add-on (coming soon): $50/month. Custom domains for questionnaires add-on (coming soon): $25/month. 30-day free trial available with no credi
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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
| - Compliance programs for SOC 2, ISO 27001, NIST 800-53, and custom frameworks
- Customer-defined controls and subcontrols
- Evidence management linked to controls
- Policy and procedure management with approval workflows
- Map one control across unlimited frameworks at no added charge
- Read-only Auditor role for direct auditor access
- Risk management tied to controls
- Trust Center with NDA-gated documents and published subprocessor list
- GraphQL API and scoped organization tokens
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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
| - Write your own control language instead of adopting vendor templates
- Open source code on GitHub with transparent pricing
- 82% less time spent on evidence collection
- Map one program across unlimited frameworks with no per-framework charge
- Unlimited users, SSO, and 2FA included in every plan with no per-seat fees
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| Community votes | 0 | 0 |
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| DR (Domain Rating by Ahrefs) | 31 ▼ −1 (down) since last check | 34 ▲ +1 (up) since last check |
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| Trust Flow (Majestic) | 23 | 12 |
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| Citation Flow (Majestic) | 40 | 29 |
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| Referring domains (Majestic) | 415 | 74 |
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Assyro AI
Openlane