A top pharma journey to enhanced compliance and efficiency

Managing the growing volume and complexity of regulatory requirements across Japan/Asia Pacific, North America and EMEA is a constant challenge for global life sciences companies. Before 2021, a top 50 pharma company’s regulatory intelligence activities were supported by regulatory affairs (RA), quality assurance (QA) and pharmacovigilance (PV) teams — on top of their existing roles. Without a centralized approach, scaling intelligence efforts globally was difficult. 

In 2021, the company established its Global Regulatory Intelligence & Policy (RI&P) function, creating a dedicated structure to lead intelligence activities, expand internal networks and provide timely, reliable insights to stakeholders across the organization. 

What the case study covers 

• The challenges of scaling global regulatory intelligence in a decentralized structure 

• Steps taken to build an effective RI&P team, including stakeholder alignment, standardized processes and accountability loops 

• How the company leveraged Cortellis Regulatory Intelligence for weekly scanning, custom research, version tracking and FDA Advisory Committee monitoring 

• Key results: faster intelligence turnaround (from days to minutes), improved cross-functional engagement, and greater organizational visibility of regulatory risks 

Why read this case study 

By implementing a dedicated global regulatory intelligence function supported by Cortellis, the company: 

• Improved preparedness across clinical, medical affairs, supply chain and manufacturing functions 

• Strengthened cross-functional communication and reduced the risk of being caught off guard by regulatory changes 

• Saved significant time by consolidating intelligence gathering into a single trusted source 

This case study demonstrates how global organizations can build a sustainable regulatory intelligence framework that enhances compliance, efficiency and collaboration. 

Download the full case study to discover how a top 50 pharma company achieved global regulatory readiness with Cortellis Regulatory Intelligence.