Overview

Multiple products, multiple markets, combined with varied Regulatory requirements challenge Life Sciences organizations to capture and maintain wide variety of information in order to obtain Health Authority (HA) approvals. Adding to this, the data generated to maintain the product lifecycle, supply chain and constantly changing market requirements would also multiply the Regulatory information management complexities. In such scenarios, the biggest task for organizations is to accurately manage the information and documents across the product life cycle and also to track it for timely updates to the health authorities. This can be achieved in different ways, but the most effective solution is a complete Regulatory Information Management System (RIM System).

Freyr PRISM is one such RIM Solution that enables Life Science organizations to effectively manage the information; right from tracking product registrations, marketing authorization lifecycles, managing product data, Regulatory document management, health authority interactions and correspondence, and to generate statistical reports. With a modular, and well-structured product data driven system that is built ground up on ISO IDMP standards, Freyr PRISM –  Product Registration Information and Submissions Management Software, assists users in future IDMP submission processes.

The RIM Software enables Life Science organizations to capture, store and maintain detailed product information as per ISO IDMP standards and allow authorized users to track country-specific registration data, including the complex European Union procedures.

 

Freyr PRISM Expertise

  • Tracking all Regulatory Submissions and Approvals
  • Product Registration Tracking and Management
  • Effective Management of Health Authority Queries, Correspondence and Interactions
  • Regulatory Document Management with Advanced Search and Storage Capabilities
  • Customizable and Effective Dashboards
  • Event Notifications and Reminders
  • Data Assessment and Migration Activities as Per ISO IDMP Standards
  • Flexible and Capable to be Integrated with Other Regulatory Applications such as Freyr Regulatory Document Management System (Freyr rDMS), Freyr SUBMIT PRO (an eCTD Software), etc.
  • Compliant with 21 CFR Part 11 and Annex 11
  • Highly Cost-Effective, On-Premise and Secured Cloud-Hosted RIM Solution
  • Flexible Pricing Model

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