The challenge
Regulatory change is constant.
Manual tracking does not scale.
Scattered sources
FDA, EMA, MHRA, and dozens more agencies. Each with different formats, update schedules, and access patterns.
Manual monitoring
Teams spend hours each week manually checking websites and comparing documents for changes.
Missed deadlines
Without systematic tracking, critical effective dates and submission deadlines slip through unnoticed.
Unclear impact
When changes are found, determining which products and markets are affected requires significant analysis.
The solution
Your control center for global regulatory intelligence
RegNexia AI consolidates regulatory monitoring into a single platform. From detection to action, stay ahead of change across every market that matters.
Monitors
Continuous surveillance of global regulatory websites and document repositories
Detects
Intelligent change detection that filters noise and surfaces what matters
Summarizes
AI-powered summaries explain what changed and why it matters
Alerts
Real-time notifications so you never miss a critical update
What changed
EMA has updated Annex I requirements for biological medicinal products, introducing new stability testing protocols effective January 2025.
Key dates
Affected areas
Capabilities
Everything you need for regulatory intelligence
Global Monitoring
Track FDA, EMA, MHRA, CDSCO, Health Canada, TGA, PMDA, and 40+ regulatory authorities worldwide.
Change Detection
Automatically detect updates to guidance documents, safety notices, and regulatory policies.
AI Summaries
AI-generated summaries explain what changed and why it matters for your organization.
Topic Classification
Automatic categorization by topic: pharmacovigilance, labeling, GMP, clinical, safety, and more.
Date Extraction
Key dates automatically identified and highlighted for compliance planning.
Custom Watchlists
Create watchlists by product, market, therapeutic area, or regulatory topic.
Smart Alerts
Email and in-app notifications configured to your team's responsibilities.
Full-text Search
Search across all monitored content with advanced filtering capabilities.
Process
How it works
Monitor
We continuously scan regulatory websites, document repositories, and official publications from global health authorities.
Detect
Our system identifies meaningful changes, filtering out noise and surfacing updates that matter to regulatory teams.
Analyze
AI summarizes each change, classifies topics, extracts key dates, and assesses potential business impact.
Alert
Your team receives targeted notifications based on watchlists, ensuring the right people know about relevant changes.
Platform
A unified intelligence dashboard
Everything your regulatory affairs team needs in one enterprise-ready interface.
Recent changes
Draft Guidance on AI/ML Medical Devices
Updated PRAC Recommendations - Signal Assessment
Revised GMP Guidelines for ATMPs
New Labeling Requirements for Biologics
Use cases
Built for teams that need to know
Regulatory Affairs
Stay ahead of guidance changes, submission requirements, and policy updates across every market your products are registered in.
Pharmacovigilance
Track safety-related regulatory updates, PRAC recommendations, and signal assessment changes from global authorities.
Biotech Teams
Monitor regulatory pathways during product development and prepare for market entry with comprehensive intelligence.
CROs & Consultants
Provide clients with proactive regulatory intelligence and demonstrate deep knowledge of evolving requirements.
Global Compliance
Ensure organizational compliance by tracking regulatory changes that affect operations across multiple jurisdictions.
Medical Affairs
Stay informed on regulatory updates that impact medical communications, labeling, and clinical evidence requirements.
Comparison
Why teams choose RegNexia
Manual website checking across 20+ regulators
Automated monitoring of all sources in one place
Days or weeks to discover critical changes
Real-time alerts within hours of publication
Reading hundreds of pages to understand impact
AI summaries that explain what changed
Siloed tracking with spreadsheets and emails
Centralized dashboard with team visibility
Missed updates affecting product compliance
Watchlists ensure nothing relevant is missed
Coverage
Global regulatory authority monitoring
Comprehensive coverage of major health authorities worldwide.
North America
Food and Drug Administration
Health Products and Food Branch
Federal Commission for Protection against Sanitary Risks
Europe
European Medicines Agency
Medicines and Healthcare products Regulatory Agency
Swiss Agency for Therapeutic Products
Federal Institute for Drugs and Medical Devices
National Agency for Medicines and Health Products Safety
Asia Pacific
Pharmaceuticals and Medical Devices Agency
National Medical Products Administration
Central Drugs Standard Control Organization
Therapeutic Goods Administration
Ministry of Food and Drug Safety
Health Sciences Authority
Latin America
National Health Surveillance Agency
National Administration of Drugs, Food and Medical Devices
National Food and Drug Surveillance Institute
Plus 40+ additional regulatory authorities across Europe, Middle East, Africa, and Southeast Asia
Security
Enterprise-ready security
Built for the compliance requirements of pharmaceutical organizations.
Role-Based Access
Granular permissions ensure team members see only what they need
Audit Trail
Complete logging of all user actions for compliance requirements
Encrypted Storage
Encrypted storage and transmission of all regulatory content
SOC 2 Compliant
Enterprise infrastructure built for regulated industries