REGULATORIA
Regulatory Intelligence & Compliance Platform
Intelligence Hub
Real-time monitoring of global regulatory changes from FDA, EMA, ICH, and more.
P0 Priority
eCTD Assembly
Automated assembly and validation of eCTD submissions (Module 1-5).
P0 Priority
Submission Tracker
End-to-end submission lifecycle management and timeline tracking.
P0 Priority
Compliance Monitor
Continuous assessment of GxP compliance status and audit readiness.
P0 Priority
Labeling Manager
Global product labeling harmonization and safety update management.
P1 Priority
Strategy AI
AI-powered regulatory pathway optimization and precedent analysis.
P1 Priority
Health Authority Portal
Centralized communication with regulatory agencies (ESG/CESP).
P1 Priority
Post-Market Surveillance
Adverse event reporting (AER), periodic safety reports, and signal detection.
P1 Priority
Change Management
Track and manage post-approval changes and variations.
P2 Priority
Global Dossier Manager
Multi-market content management and lifecycle tracking.
P2 Priority