Pace Life Sciences Completes FDA Inspection at Small Molecule Center of Excellence

Editor’s Take: Research Triangle Park is a life sciences powerhouse because it sits at the intersection of world-class universities, a deep scientific workforce, strong state support, lower costs and decades of biotech clustering, creating an environment where pharma and biotech companies can grow efficiently.

Pace Life Sciences, a U.S.-based, FDA-registered GMP analytical testing laboratory and full-service contract research, development and manufacturing organization (CDMO), has successfully completed a U.S. Food and Drug Administration (FDA) inspection of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina.

“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,” said Lou Forcellini, Head of Quality Assurance at Pace Life Sciences. “Each successful inspection strengthens our clients’ confidence in our capabilities and reinforces our mission to deliver reliable, high-quality results that ultimately help improve patient lives.”

The Research Triangle Park facility provides comprehensive analytical support throughout the drug development and manufacturing lifecycle, including:

• Storage and stability testing
• Extractables and leachables (E&L) testing across container closure systems and manufacturing materials
• Analytical method development and validation
• Organic spectroscopy for the characterization, quantitation and identification of small and large molecules

More Pace Life Sciences News

Last year, Pace Life Sciences remodeled and expanded its Salem, New Hampshire site to establish a Center of Excellence for Aseptic Fill-Finish Processing.