Stop manually checking regulatory websites. RegNexia AI monitors 50+ global authorities and delivers actionable intelligence directly to your team — so you can focus on strategy, not surveillance.
50+
Regulatory authorities
4
Continents covered
24/7
Continuous monitoring
AI
Powered analysis
Challenges
Guidance documents change without warning
Continuous 24/7 monitoring of all major regulatory authorities surfaces changes within hours of publication — not days.
Tracking across 20+ agencies is unsustainable
One unified dashboard consolidates FDA, EMA, MHRA, Health Canada, TGA, PMDA, and 40+ more into a single feed.
Understanding impact takes too long
AI-generated summaries explain what changed, which products or markets are affected, and what action is required.
Compliance deadlines slip through the cracks
Automatic date extraction flags effective dates and submission deadlines so nothing is missed.
Capabilities
Automatically detect updates to FDA guidance documents, EMA guidelines, ICH documents, and regional regulatory policies the moment they are published.
Stay on top of changing submission formats, eCTD requirements, and dossier standards across all markets where you operate.
Track changes to accelerated approval pathways, breakthrough therapy designations, and conditional marketing authorization criteria.
Create watchlists by product, therapeutic area, or market so each team member only sees what is relevant to their portfolio.
AI summarizes each regulatory change and assesses its impact on your filings, approvals, and ongoing submissions.
Key dates extracted automatically from every document feed into a centralized timeline for implementation deadlines and comment periods.
Use Cases
Head of Regulatory Affairs
Gets a morning digest of all meaningful regulatory changes across all markets, with AI-prioritized impact flags — before the team meeting.
Regulatory Submission Manager
Receives an alert when the FDA updates its eCTD technical specifications, with a summary of exactly what changed and by when compliance is required.
Regional Regulatory Lead
Monitors EMA, MHRA, and Swissmedic simultaneously without switching between three websites, with region-specific watchlists by product.
Regulatory Intelligence Analyst
Generates a competitive regulatory landscape report in minutes using full-text search and export across all monitored authorities.
Coverage
Monitor every major regulatory authority from a single platform — with 40+ more beyond this list.