Division of medical technology company Pace, Pace Life Sciences, has completed a European Medicines Agency (EMA) Good Manufacturing Practice (GMP) inspection at its Lebanon, New Jersey facility as part of its EU GMP certificate renewal process.
Pace Life Sciences is a US-based, FDA-registered GMP analytical testing laboratory and full-service contract development and manufacturing organisation (CDMO).
The inspection conducted on October 13 and 14, 2026, assessed the site’s quality systems and laboratory operations, including stability programs, equipment qualification, sample receipt and management, employee training, corrective and preventive actions (CAPA), analytical procedures, data packages, and container closure integrity testing activities. A renewed EU GMP certificate is expected to be issued.
“Our customers rely on defensible analytical data to bring safe, effective therapies to patients worldwide,” said Lou Forcellini, VP of Quality Assurance at Pace Life Sciences. “This achievement reflects our team’s commitment to operational excellence and reinforces our ability to operate within rigorous international regulatory frameworks while delivering the reliable, high-quality data our clients depend on.”
“The successful EMA inspection further demonstrates the strength of our quality systems and the depth of regulatory expertise at our Lebanon site,” said Amanda Yoakum, Senior Director and Site Lead. “As pharmaceutical development and supply chains become increasingly global, we remain committed to helping our clients navigate complex regulatory expectations, advance their programs with confidence, and ultimately support the safety and efficacy of therapies reaching patients around the world.”
The 40,000-square-foot facility provides analytical testing and development support for pharmaceutical and biopharmaceutical companies including container closure integrity testing (CCIT), stability testing, analytical method development and validation, and microbiology testing.
Pace® is a portfolio company of Leonard Green & Partners and Los Angeles-based Aurora Capital Partners.
ABOUT PACE® LIFE SCIENCES
Pace® Life Sciences delivers scientific certainty to pharmaceutical and biopharmaceutical clients, developing life-changing therapies. From early R&D and clinical trial materials production to analytical testing and commercial-stage support, Pace® works closely with clients to reduce risk, anticipate challenges, and keep critical programs moving forward. Across its network of U.S.-based facilities, Pace® also provides regulatory, quality, and laboratory operations support, helping clients strengthen compliance, and improve internal processes to address evolving business and scientific needs. By combining expertise, responsive service, and a partnership-led approach, Pace® helps clients move forward with greater clarity and confidence.
