From Design To Operation: Supporting GMP Facility Readiness

Eurofins PSS Insourcing Solutions® partners with biotech and pharmaceutical companies to ensure successful GMP facility readiness, from design to operation. With more than 20 years of experience, Eurofins PSS has a proven track record in validating and opening new or remodeled facilities that meet stringent regulatory requirements. Their client-focused, flexible model integrates seamlessly with internal teams and third-party vendors, providing comprehensive lifecycle support that spans construction, validation, and ongoing operations.

Services include facility design consultation, equipment selection, and robust validation processes such as installation, troubleshooting, Environmental Monitoring Performance Qualification (EMPQ), and water and gas testing. Eurofins also assists with implementing and maintaining quality control systems, ensuring long-term compliance and audit readiness. Through their Operational Excellence program, they have generated over $37 million in client savings since 2017.

A defining strength of Eurofins PSS lies in its emphasis on personnel training and knowledge transfer. By developing client-approved subject matter experts, they build sustainable capabilities that reduce internal burden and ensure continuity as operations expand. Staff are trained to operate within client quality systems from day one, with support available for SOP creation, documentation, and even direct training of client employees in key GMP practices.

Beyond startup, Eurofins provides ongoing operational support, continuous improvement, and project management to keep facilities compliant with FDA, EMA, and ISO standards. Their unmatched flexibility, collaborative approach, and access to Eurofins’ broader network position them as a trusted partner in creating efficient, compliant, and future-ready GMP facilities.