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Customized Regulatory Intelligence Ecosystem for a Global Biopharma Leader
- Abstract
- Problem Statement
Step into the transformation journey of a top 5 global bio-pharmaceutical leader who partnered with Freyr GRI to revolutionize their fragmented Regulatory Intelligence ecosystem. Operating across 50+ therapeutic areas, the industry giant faced the complexities of managing multiple siloed systems that impeded efficient regulatory operations. Through a Custom-Built Enterprise solution, Freyr GRI unified their regulatory infrastructure, enabling data-driven decision-making and streamlining their compliance management.
- Complex regulatory data management spread across 7 disconnected systems, creating operational inefficiencies
- Absence of a unified framework for monitoring and tracking regulatory changes across multiple geographies and therapeutic areas
- Challenge of managing millions of regulatory requirement records without a centralized system
- Lack of comprehensive workflow management leading to escalating operational costs
- Existing market solutions inadequate to address enterprise-scale requirements and complexity
- Limited ability to leverage Regulatory Intelligence for strategic decision-making and market expansion
