| What it does | Professional alert device for guaranteed compliance
| AI regulatory submission software that cuts 6+ weeks and $250K of rework from every submission cycle
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| Stage | Not given
| Startup
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| Founded | Not given
| 2024
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| Based in | FR
| Not given
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| Pricing model | Freemium
| Contact for pricing
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| Pricing | Tiers based on company size: 1-49 employees €29/month, 50-249 employees €59/month, 250-999 employees €79/month, 1000+ employees €99/month. All plans include unlimited users, cases, storage and support.
| 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.
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| Key features | - 100% anonymous reporting for employees
- Two-way conversation while preserving anonymity
- Automated acknowledgments and responses
- Customizable reporting categories
- AI-powered sentiment analysis
- Quick setup in 10 minutes
- Multilingual support
- GDPR and EU whistleblower directive compliant
- Intuitive dashboard and reporting tools
| - 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
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| What makes it different | - Detects fraud 50% faster than organizations without a reporting channel
- Fully compliant with EU whistleblower directive and French Sapin II law
- All plans include unlimited users, cases, storage and support
- Recommended number one alert solution by HR professionals
- No IT expertise required for setup and management
| - 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
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| Community votes | 0 | 0 |
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| DR (Domain Rating by Ahrefs) | 32 ▲ +22 (up) since last check | 31 ▼ −1 (down) since last check |
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| Trust Flow (Majestic) | 23 | 23 |
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| Citation Flow (Majestic) | 25 | 40 |
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| Referring domains (Majestic) | 71 | 415 |
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TrustBox
Assyro AI