Business Imperatives

  • An EU-based multinational innovator pharmaceutical company was having difficulties staying up to date with relevant and time-critical Regulatory information coming from multiple sources and geographies despite having a solid Regulatory Affairs team.
  • Internal services and tools were not adequate for accelerated & holistic decision-making.
  • As a result, the company was taking a reactive approach for their global brands leading to a risk of the brands being adversely affected in the global markets due to Regulatory non-compliance.


  • To help an EU based multinational pharmaceutical company increase process efficiency in Regulatory intelligence and decrease people and technology costs while maintaining compliance with a robust Regulatory intelligence platform.

Problem Statement

  • Deluge of information from existing multiple tools yet lack of relevant, actionable intelligence
  • Lack of clearly defined processes to manage relevant global RI data
  • Non-harmonized data categorization across multiple tools
  • Integrate downstream and upstream processes and data with a centralized Regulatory Intelligence eco system.
  • Limited inhouse resources in RI team to centralize and manage the data
  • High cross-functional dependency with no defined roles and responsibilities

Freyr Solutions and Services

Freyr Solutions and Services
  • 5 step RI consulting approach; Understanding the existing Regulatory setup, Gap Analysis of the current approach towards people, process and technology, Proposing a holistic scheme for efficient RI operations, Validation of the plan and implementation
  • Proposed plan for a centralized, harmonized RI process and data management platform
  • Significantly reduced compliance costs via lowered dependence on multiple tools and cross-functional teams
  • Cementing the client’s position in the market via enhanced compliance by ensuring the development of a sustainable and long-term RI strategy
  • Accelerated Decision-making via Regulatory Analytics
  • 60% Increase in process efficiency
  • 30% Reduction in technology and people cost
  • One Centralized RI solution