Regulatory
Information
Management (RIM)
for Pharma Biotech
A unified platform for Pharma & Biotech to streamline product registration, manage global submissions, and ensure regulatory compliance efficiently.
Global Visibility
Gain a single source of truth for all product registrations and market authorizations worldwide. Track
status in real-time.
Submission Planning
Efficiently plan and track regulatory activities. Manage submission content plans and timelines to ensure rapid market access.
Compliance Tracking
Data hosted in ISO 27001 certified data centers (USA/Germany). Full GDPR compliance with audit-ready documents and validation.
XEVMPD & IDMP
Built-in support for data standards including XEVMPD and IDMP, ensuring your data is structured for future compliance.
Seamless Integration
Integrates with Document Management Systems (EDMS), Publishing tools, and Labeling systems for a connected regulatory ecosystem.
Advanced Analytics
Dashboard analytics provide insights into submission volume, approval times, and workload distribution across regions.
Related Tools & Solutions
Regulatory Impact Assessment (RIA)
Submission Management
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