AI compliance platform for life sciences that automates quality workflows and regulatory monitoring
FDA warning-letter and enforcement intelligence delivered as a daily brief
Stage
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Founded
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Based in
IE
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Pricing model
Contact for pricing
Freemium
Pricing
Foundation plan available; Growth plan available; Scale plan custom pricing. Annual recurring subscription model. All plans include cloud storage and platform updates.
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
Document Control
Training Management
Supplier Quality Management
CAPA Management
AI-powered Gap Analysis
Compliance Intelligence with AI agents
Risk Management
Design Control Management
Change Control Management
Audit Management
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
80% less audit prep time
5x ROI in 2 months
AI agents automate regulatory monitoring across 28+ frameworks
Live within 30 days with expert-led implementation
Cross-map evidence once, reuse across submissions
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
Qualio