FDA warning-letter and enforcement intelligence delivered as a daily brief
Stage
Not given
Not given
Founded
Not given
Not given
Based in
US
Not given
Pricing model
Freemium
Freemium
Pricing
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
Starter: free. Professional: $49/month. Enterprise: $199/month. Annual plans available at 20% discount. Payment via card (Polar or Lemon Squeezy) or crypto (USDT, USDC, SOL via xpayr). Cancel anytime.
Key features
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
Filter by product type (device, drug, biologics, food, tobacco)
Company watchlists with instant notifications
Same-day alerts (Professional and Enterprise plans)
Searchable historical archive back to 2022
Email and Telegram delivery
CSV and API export
Customizable daily or weekly briefing schedule
API access and webhooks (Enterprise)
Slack and Teams delivery (Enterprise)
Multiple user seats (Enterprise)
What makes it different
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
Data normalized and classified from official FDA sources daily
Briefing designed to be scanned in 60 seconds
Precision filtering eliminates irrelevant alerts
Highest ROI for CDMO/CMO business development teams