Regulatory Information Management
RIM enables life sciences organizations to manage product information, registrations, submissions, lifecycle activities, Health Authority interactions, regulatory data, and reporting in one connected platform. It improves visibility, compliance, traceability, and informed regulatory decision-making across global markets.
From Fragmented Regulatory Data toConnected Lifecycle Management
Regulatory teams manage complex product portfolios, global registrations, submissions, Health Authority interactions, lifecycle events, and compliance requirements across systems. RIM connects product data, regulatory activities, documents, workflows, and analytics to provide complete visibility from strategy through approval and post-approval lifecycle management.
Key Regulatory Information Management Capabilities
Application & Registration Management
- Product Application Management
- Submission & Content Plan Management
- Product Registration Tracking
Health Authority Interaction Management
- Health Authority Correspondence
- Questions, Meetings & Responses
- Commitments & Inspections
Regulatory Reporting & Analytics
- Regulatory Portfolio Dashboards
- Submission & Approval Tracking
- Lifecycle & Compliance Analytics
Lifecycle Management
- Lifecycle Event Management
- Regulatory Activities & Assessments
- Post-Approval Submission Management
Regulatory Master Data Management
- Product, Country & Health Authority Masters
- Organization & Site Masters
- Submission Type & Controlled Vocabulary
Connected Regulatory Lifecycle
Powered by a Unified Regulatory Platform
Assisted Author works within the connected RegX™ regulatory environment, supported by:
Master Data Foundation
Centralized Document Hub
Workflow & Automation
End-to-End Traceability
Regulatory Analytics
Business Value of RegX™ RIM
Complete Regulatory Visibility
Gain a unified view of products, registrations, submissions, lifecycle events, and regulatory activities.
Standardized Processes
Improve consistency through structured workflows and controlled regulatory processes.
Stronger Compliance
Maintain traceability, governance, audit history, and inspection-ready regulatory records.
Reduced Manual Effort
Replace disconnected tracking methods with centralized regulatory workflows.
Better Data Quality
Improve accuracy, consistency, and reliability of regulatory information.
Global Readiness
Support regulatory operations across markets with connected information and lifecycle visibility.
Transform Regulatory Information Management with RegX™
RegX™ RIM provides a connected regulatory foundation to manage applications, registrations, lifecycle activities, Health Authority interactions, master data, and reporting—helping life sciences organizations improve regulatory visibility, strengthen compliance, and manage the complete product lifecycle with confidence.