ReALM® Regulatory Information Management (RIM) Platform

par Orion Systems Integrators, LLC

"Global Regulatory Intelligence", "Submissions Planning", "Registration Tracking", "HA Interactions"

ReALM® is a Regulatory Information Management RIM platform (SaaS) with applications to manage Regulatory Intelligence, Submissions Planning, Registration Tracking and Health Authority Interactions for Pharmaceutical and Medical Devices companies.

The ReALM® Regulatory Information Management (RIM) platform is:

  • A cloud-first application designed for easy scale up
  • Powered by Microsoft technologies on Windows Azure
  • Flexible, configurable, and easily deployed to address client-specific needs

ReALM® comes with four key modules:

  1. ReALM® Regulatory Intelligence to streamline curation and management of global regulatory requirements and actionable regulatory intelligence.
  2. ReALM® Submissions Planning to create and manage country-level and dossier-level table of contents planning, driven by regulatory intelligence.
  3. ReALM® Registrations to streamline product registration, site registration, and lifecycle management activities and events.
  4. ReALM® Interactions to capture and manage queries, correspondence, and commitments with health authorities worldwide.

ReALM® Benefits include:

  1. End-to-end platform with the ability to quickly configure and deploy to clients and on-board end users.
  2. Increases efficiencies, and reduces cycle time/re-work across the regulatory value chain.
  3. Support for DIA RIM Reference Model.
  4. Support integration across the RIM value chain through interfaces.
  5. Support data quality and compliance.

With Regulatory becoming increasingly digital and end-to-end, this platform is especially suitable for small and medium size companies that are struggling with Excel or SharePoint to manage regulatory information in sustainable ways, in order to streamline regulatory activities. ReALM brings multiple functional needs under one umbrella. It all starts with getting upstream regulatory intelligence in the form of actionable checklists which drive downstream activities.

Vue d’ensemble