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Regulatory Intelligence Eco System Transformation for a Leading Global Bio-Pharmaceutical Company

About Customer

Global top 5 biopharmaceutical company headquartered in the US, with a focus on 50+ therapeutics and products (pharmaceuticals, biosimilars, medical devices, etc.)

Business Need

Comprehensive Regulatory intelligence solution with streamlined processes and integrated platform to address the following business needs

  • Change the current Regulatory intelligence repository to enable critical decision-making processes.
  • Introduce innovative technologies including robotic process automation/AI/ML to support automated data capture, cleanse and manage with the changing global Regulatory requirements including polices and guidance's.
  • Capture global Regulatory Health Authority requirements in real-time and distribute for consumption & timely decision making.
  • Provide insights on how global Regulatory changes might affect current product submissions and upcoming market-specific product submission strategies.
  • Replace 100’s of small applications and file-based data management tools with a central platform.

Key Objectives

  • Real-time global Regulatory requirements management ready for consumption and decision making
  • Track global Health Authority policies /guidance's, enable impact assessment and change control
  • Regulatory strategy and filing plans that are driven by on-the-ground market intelligence and precedence data
  • Integrate downstream, and upstream processes and data with a centralized Regulatory Intelligence eco system.
  • Redefine the current RI repository and processes for a scalable data management and smart decisions framework enabled by progressive technologies.
  • Integrates with publishing systems such as GPS (Lorenz - DocuBridge)


  • Regulatory Affairs Function
  • Labeling
  • Submission Operations
  • Clinical Trial Data Operations
  • Regulatory Policy Management
  • All Global Markets ( 150+)
  • No of Users 4000+
  • No of Processes ~ 90+

Freyr Solution Offered

  • Global Regulatory intelligence process and solution enablement consulting (Current state Assessment, Gap Analysis and Future Blue-print)
  • Subscription to Freyr IMPACT software services
  • Migration of 2.9 Mn+ existing records from Oracle database to Freyr IMPACT database
  • New APIs are configured to enable the change assessment system to extract the required data from Freyr IMPACT
  • Additional APIs are configured for the internal and external systems which requires inputs/data from Freyr IMPACT
  • Global Regulatory requirements for submission strategy, defining critical parameters and scenarios for market entry for Pharmaceutical products across the markets
  • Cross country comparison of global Regulatory markets to strategize focused market entry
  • Tracking, compliance with the latest regulations, alerts through email notifications, and Regulatory analytics
  • Global dashboard with actionable insights and SME synopsis and recommendations

Implementation Timeline

  1. Planning & Requirement Gathering


    2.9+ Mn Records Migrated


  2. Data Mapping


    108+ Active Change Types


  3. Configuration


    175+ Questions per Change Type


  4. Testing


    150+ Countries


  5. Deployment & User Training


    465+ Questions per Country


Key Benefits Delivered

  • Easy Data Migration:2.9 Mn+ records migrated with automated functionalities enabled with APIs and RESTful services
  • Centralized Platform:Single source of information for change controls and Regulatory impact assessment
  • Automation BOTs:For continuous tracking and auto-updating of new regulations with structured workflow and simplified processes
  • Simple and Configurable Workflows:Configurable workflows for different processes and groups
  • No Limitation of Characters:Freyr IMPACT can be used for planning workbook for all LATAM countries

Platform Advantage

Cloud Solution:

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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