FDA warning-letter and enforcement intelligence delivered as a daily brief
Stage
Not given
Not given
Founded
2023
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Based in
SE
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Pricing model
Contact for pricing
Freemium
Pricing
Free initial compliance gap analysis with no commitment required.
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
Policy and regulation upload with automatic organization into unified rulebook
AI-powered gap detection between regulations and existing policies
Source traceability linking every rule to its exact source
Control and task assignment with named owners
Evidence verification against requirements with AI assistance
Regulatory change monitoring and impact tracking
Contract review and linking to company rules
Model Context Protocol integration with AI tools
Daily work dashboard with evidence requests and policy approvals
Centralized rulebook connected to policies, regulations and contracts
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
Human approval required for all AI recommendations and decisions
Complete source traceability connecting rules back to original requirements
Industry-specific starting points for banking, critical infrastructure, public sector and healthcare
AI handles structure and organization while people make all compliance decisions
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
Hybridity