| What it does | AI regulatory submission software that cuts 6+ weeks and $250K of rework from every submission cycle
| Supplier and third-party risk monitoring by email
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| Stage | Startup
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| Founded | 2024
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| Based in | Not given
| PL
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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: 30-day watch of up to 10 companies with baseline report, alerts, weekly and monthly reports. Watch: $499/month or $4,990/year (USD), €459/month or €4,590/year (EUR) for up to 50 companies with financial and legal risk monitoring, baseline report, verified alerts, weekly and monthly reports. Co
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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
| - Daily monitoring of public records including court filings, insolvency records, sanctions lists and regulatory notices
- Company list resolved to legal entities with identifiers before monitoring starts
- Five-year baseline report on each watched company
- Email alerts when events cross your defined risk line
- Weekly watch logs showing what was checked, what crossed your line, and what stayed below it
- Source-specific monitoring with sources chosen per country and company type
- Multilingual monitoring with alerts sent in your language
- Dated monthly reports ready for auditors
- No portal or login required; all communication by email
- Privacy built in: no cookies, tracking, analytics, or data pooling across customers
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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
| - Watches public records daily, not questionnaires, for real-time risk detection
- Alerts include the verified source document linked, not just a summary
- Covers suppliers anywhere in the world by reading sources in their original language
- Monthly dated reports and evidence exports shaped to regulatory audit requirements
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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 | 3 |
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| Citation Flow (Majestic) | 40 | 24 |
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| Referring domains (Majestic) | 415 | 39 |
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Assyro AI
Noctovisor