Case Study: Global Pharmaceutical Company achieves reduced quality risk and streamlined regulatory processes with Sphera's Advanced Risk Assessment

Reduce Quality Risk and Streamline Regulatory Processes

Global Pharmaceutical Company, a global pharma leader (33,000+ employees, $22.3B revenue), faced growing quality‑risk and regulatory complexity as it moved into biopharma. Risk assessments were managed with spreadsheets and large process-flow documents across 62+ countries, making complaint investigations slow and reporting manual—so the company engaged Sphera and its Advanced Risk Assessment (ARA) solution to centralize risk management.

Sphera deployed its Advanced Risk Assessment (ARA) platform to connect PHAs, FMEAs and control strategies, standardize data capture and roll out a centralized process to 500+ users in five countries. With Sphera’s solution the company now produces compliance reports in minutes rather than months, realized significant time savings, saved millions of dollars on complaint investigations, and reduced product defects and costly recalls, with plans to expand ARA to more sites.