Huvepharma Maintains Quality And Regulatory Compliance To Support Rapid Global Growth

Huvepharma, a dynamic global pharmaceutical company based in Sofia, Bulgaria, is making significant strides in human and animal health products. With manufacturing facilities in Bulgaria, Italy, France, and the US, and over 90 affiliates worldwide, the company is committed to delivering safe and high-quality products. To support its ambitious growth trajectory and maintain regulatory compliance, Huvepharma recognized the necessity of implementing a comprehensive quality management system (QMS). Faced with complex compliance challenges across diverse global regulations and traditional manual processes, Huvepharma sought to standardize its quality processes and documentation.

The company selected ETQ Reliance for its flexibility and compliance with FDA and EU standards, allowing for essential features such as electronic signatures and audit trail traceability. This robust platform has facilitated the integration of quality management processes across 12,000 users, enhancing data-driven decision-making and expediting corrective actions. The implementation of ETQ Reliance has already yielded significant improvements in compliance and efficiency, particularly in managing customer complaints. Huvepharma plans to further enhance its quality management capabilities by integrating training management and supplier qualification applications.

By harmonizing operations and improving oversight, Huvepharma is poised to continue its rapid growth while ensuring adherence to evolving regulatory standards. Access the full case study to learn more.