Business Imperatives

  • A global top 5 bio-pharmaceutical company headquartered in the USA, dealing with pharmaceuticals, biologicals and medical devices focusing on 50+ therapeutic areas.
  • The company requires an advanced and comprehensive Regulatory intelligence solution with streamlined processes to monitor and track global regulations and enable better strategic decision making.

Objectives

  • Change the current Regulatory intelligence repository to enable critical decision-making processes and introduce innovative technologies including robotic process automation / AI / ML to support automated data capture, cleanse and manage changing global Regulatory requirements including polices, guidance's.
  • Provide insights into how global Regulatory changes might affect current product submissions and upcoming market specific product submission strategies.

Problem Statement

  • Client needed a real-time Global Regulatory Requirements Management platform ready for consumption and decision making.
  • Platform should be able to track global Health Authority Policy / Guidance, enable Impact assessment and Change control.
  • Wanted to create Regulatory Strategy and Filing Plans driven by on the ground market intelligence and precedence data.
  • Wished to integrate downstream and upstream processes and data with a centralized Regulatory Intelligence eco system.
  • Aspired to redefine the current RI Repository and processes for a scalable data management and smart decisions framework enabled by progressive technologies.

Freyr Solutions and Services

Freyr Solutions and Services
  • Global Regulatory Intelligence Process and Solution enablement Consulting (Current state Assessment, Gap Analysis and Future Blueprint).
  • Migration of 14 Mn+ existing records from Oracle database to Freyr IMPACT database.
  • Additional APIs configured for the internal and external systems which requires inputs/data from Freyr IMPACT.
  • Tracking, compliance with the latest regulations, alerts through email notifications, and Regulatory analytics.
  • Cross Country Comparison of Global Regulatory markets to strategize focused market entry.
  • A single point solution to effectively manage the millions of Regulatory requirement records across multiple markets and product types.
  • An access controlled, secure system with role based user privileges leading to increased adoption at an organization level.
  • More than 14 M records migrated into one system.
  • 110+ custom features developed.
  • 7 to 1 reduction in digital footprint.
  • Enabled holistic decision making through data centralization.