Regulatory Affairs Lifecycle Management Platform (ReALM^®)

Orion’s ReALM^® is a cloud-based platform that transforms the regulatory value chain in the Life Sciences industry. Key modules support the streamlining of upstream activities such as regulatory strategy, submissions planning and downstream activities such as registration tracking and health authority interactions, including the ability to integrate with other enterprise or cloud applications.

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

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.

Watch the video of Regulatory Intelligence & Submissions Planning modules

Further Reading

Learn more about our Cloud & Infrastructure services and Regulatory Information Management services.

Watch our Life Sciences webinar on demand: How Emerging Life Sciences Companies are Transforming Product Registrations with Technology.