| What it does | AI regulatory submission software that cuts 6+ weeks and $250K of rework from every submission cycle
| Send policies to the right people, collect confirmations and follow up automatically
|
|---|
| Stage | Startup
| Not given
|
|---|
| Founded | 2024
| Not given
|
|---|
| Based in | Not given
| Not given
|
|---|
| Pricing model | Contact for pricing
| Not given
|
|---|
| 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 plan: up to 10 recipients, $0/month. Standard: up to 75 recipients at $49/month, up to 250 recipients at $79/month, up to 1,000 recipients at $139/month. All plans include standard features. Add-ons: Learning courses from $29-$99/month, Policy Intelligence from $99-$199/month. Enterprise plans
|
|---|
| 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
| - Version control with tracked document updates
- Smart targeting by department, location, role or custom groups
- Automated reminders and follow-up without manual chasing
- Magic link access without accounts or passwords
- Policy portal showing all relevant policies and confirmation status
|
|---|
| 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
| - Flexible process that adapts to how your organization works, not the other way around
- Recipients confirm with secure personal links, no accounts or passwords required
- Version-linked, audit-ready records ready when auditors or customers ask
- Built specifically for ISO 27001, SOC 2, GDPR and similar compliance frameworks
- No IT setup required; works immediately with CSV import or manual setup
|
|---|
| Community votes | 0 | 0 |
|---|
| DR (Domain Rating by Ahrefs) | 31 ▼ −1 (down) since last check | 19 ● no change since last check |
|---|
| Trust Flow (Majestic) | 23 | 16 |
|---|
| Citation Flow (Majestic) | 40 | 20 |
|---|
| Referring domains (Majestic) | 415 | 86 |
|---|
Assyro AI
Policy Confirm