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RIM Implementation for Japan-based Global Pharma Organization

About Customer

Japan-based global Pharmaceutical major with focus on innovative pharmaceutical and nutraceuticals products.

Business Need

The goal was to implement a cost-effective RIMS for the customer and all affiliates as an on-premises deployment for:

  • Global product registrations and their marketing statuses
  • Clinical trial applications including IND, CTPN
  • Tracking lifecycle management and submissions variations including safety label variations and CMC information
  • Support customer’s future IDMP responsibilities based on global Health Authorities regulations and requirements

Key Objectives

To track, manage, and efficiently enable Regulatory submissions from investigation through commercialization.

  • Accommodates current/ evolving IDMP guidelines
  • Supports current RIMS functionality, plus includes additional requirements
  • Allows  expanded global and affiliate access such as OPCJ, OPDC, OCPI, ODCE, OEDC, KOIAA, and Taiho (US & Japan)
  • Provides enhancement analytics and reporting capabilities
  • Integrates with Electronic Document Management System (EDMS) such as CRED (Generis - CARA)
  • Integrates with publishing system such as GPS (Lorenz - DocuBridge)


  • Nearly 100 product families, including 250 individual products
  • Over 3,000 product registrations across 120+ countries
  • 300 users globally, covering the US, Canada, Europe, and Asia, and managing the company as well as its affiliates separately – all within the same instance

Freyr Solution Offered

  • SPAR integrated the customer’s existing DMS and provided high storage capabilities
  • Data migrated from the existing tool to SPAR, achieved by mapping of the UI fields to the SPAR database with AQL scripts
  • SPAR provided the ability to track any Regulatory scenario effectively. That includes - tracking global product registrations, managing Regulatory documents, Health Authority interactions, and commitments & obligations.

Implementation Timeline

  1. RFI and RFP submission


    100+ Product Families

    Feb – Apr’ 20

  2. Demonstration


    250+ Individual Products


  3. Kick-Off


    3000+ Product Registrations


  4. User Acceptance Testing


    120+ Countries


  5. Go-Live


    300+ Users Globally


Key Benefits Delivered

Solution Advantage

  • Hassle free data entry and management with existing Freyr centralized data entry team.
  • Future readiness for IDMP submissions.
  • Compatibility with customer’s existing DMS.
  • Smooth and untangled workflow of data entry, verification, and maintenance.
  • As SPAR is partially aligned with IDMP requirements as of today (IDMP EU IG v1.0), the quality of the data managed is compliant with EMA.
  • Customer is now able to track such global submissions effectively unlike their legacy RIMS.
  • Customer has developed new processes around the tool for effective tracking of Global Safety Label variations.

Platform Advantage

On-Premise and Cloud Solution:

On-Premise and Cloud based platform offering 24X7 accessibility and availability

Configurable Web- Based Solution:

Web-based solution offering dynamic feature - rich modules which are highly configurable

Flexible Integration:

Flexibility in integrating with Freyr’s Software Suite as well as with any third-party Regulatory tools using APIs

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