CPHI Milan newsletter
PCI High Potent Manufacturing
LB Bohle – 10.06.2025
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Pace Life Sciences Announces Compliant US FDA Inspection of Operations in Research Triangle Park, NC

Proven track record of consistent high quality confirmed at Pace® Life Sciences

Pace® Life Sciences, a U.S.-based, FDA-registered GMP analytical testing laboratory and full-service contract research, development, and manufacturing organization (CDMO), and a Division of Pace®, a Science and Technology Company, today 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.

This milestone marks another successful FDA inspection across the analytical operations at Pace® Life Sciences, reinforcing the organization’s long-standing commitment to quality, regulatory compliance, and data integrity.

“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

Pace® is a portfolio company of Leonard Green & Partners and Los Angeles-based Aurora Capital Partners.

ABOUT PACE® LIFE SCIENCES
Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of GMP analytical testing laboratories and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business.

ABOUT PACE®
Pace® makes the world a safer, healthier place. Pace® people are committed to advancing the science of the pharmaceutical and biotechnology industries in our Life sciences laboratories and supporting businesses, industries, consulting firms, government agencies, and more in our Analytical Services Laboratories. Pace® offers local-level service backed by a national laboratory network. For customers with in-house labs, Pace® provides a range of professional services to keep their operations moving forward. Pace® people work in partnership with customers by providing the service, science and data they need to make critical decisions that benefit us all.

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