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Establishing 360° Regulatory Intelligence for a Leading EU Pharma Innovator
- Abstract
- Problem Statement:
Explore how Freyr GRI enabled a prominent EU pharmaceutical innovator to build a comprehensive Regulatory Intelligence (RI) framework from the ground up. Leveraging 360° regulatory consulting and strategic staffing solutions, we established a centralized RI ecosystem, harmonized data categorization, and streamlined cross-functional workflows. As a result, the client achieved a 60% increase in process efficiency, 70% reduction in regulatory research time, and significant cost savings, ensuring sustained compliance and operational excellence.
- Disconnected tools created information overload, limiting actionable insights for regulatory compliance.
- Lack of standardized processes for managing global RI data led to inefficiencies and compliance risks.
- Non-harmonized data categorization across systems caused inconsistencies in regulatory tracking.
- Limited in-house RI expertise increased cross-functional dependencies and delays.
- A reactive approach to regulatory updates heightened risks of non-compliance in global markets.
