- Pace Life Sciences announced the successful completion of a U.S. Food and Drug Administration (FDA) inspection of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina.
- The FDA-registered GMP analytical testing laboratory said the inspection reinforces its commitment to quality, regulatory compliance, and data integrity across its analytical operations.
Pace Life Sciences announced the successful completion of a U.S. Food and Drug Administration (FDA) inspection of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina. The facility is part of the company’s FDA-registered GMP analytical testing laboratory network and supports its contract research, development, and manufacturing organization (CDMO) and contract manufacturing services.
The company said the inspection represents another successful FDA review across its analytical operations and reflects its focus on quality, regulatory compliance, and data integrity. The Research Triangle Park facility provides analytical support throughout the drug development and manufacturing lifecycle.
The site’s capabilities include storage and stability testing, extractables and leachables (E&L) testing for container closure systems and manufacturing materials, analytical method development and validation, and organic spectroscopy for the characterization, quantitation, and identification of small and large molecules.
“Achieving consistent positive FDA inspection outcomes across our analytical network reflects the strength of our quality systems, the expertise of our staff, and our unwavering commitment to scientific excellence.”
Lou Forcellini, Head of Quality Assurance at Pace Life Sciences
Pace Life Sciences added that the successful inspection supports its efforts to deliver analytical services for pharmaceutical development and manufacturing. The company is a portfolio company of Leonard Green & Partners and Aurora Capital Partners.