Research Triangle Park, NC site received a positive FDA Review, marking a milestone as all company Analytical Outsourcing sites have achieved successful recent inspections
MINNEAPOLIS, MINNESOTA / ACCESS Newswire / July 29, 2025 / Pace®?Life Sciences, a U.S.-based full-service FDA-registered GMP Analytical Testing laboratory and contract, research, development and manufacturing organization (CRDMO) and a Division of Pace®, a Science and Technology Company, received a successful outcome following a recent inspection by The Food & Drug Administration (FDA) of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina.
Pace Life Sciences employee employs the dissolution at the Research Triangle Park, NC facility.
This inspection marks the fourth straight positive FDA review of Pace® Life Sciences quality systems and regulatory compliance in the last 15 months. Earlier inspections occurred at Pace® facilities in Oakdale, MN; San German, PR; and Lebanon, NJ. "Achieving positive FDA outcomes at all our major analytical sites reinforces our dedication to data integrity, compliance, and robust quality systems," stated Lou Forcellini, Head of Quality Assurance at Pace® Life Sciences. "This milestone not only strengthens clients' trust in our capabilities but supports our commitment to improving patient lives."
The Research Triangle Park laboratory acquired from Catalent in 2024 plays a key role in supporting pharmaceutical and biopharmaceutical clients. The facility provides a wide range of analytical services across the entire drug development and manufacturing process, including storage and stability testing, testing for extractable and leachable impurities in products across container/closure materials, method development and validation, and 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.
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ABOUT PACE® LIFE SCIENCES
Pace® Life Sciences provides a full suite of contract CMC development, clinical trial 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. More at PACELIFESCIENCES.com.
Contact Information
Pam Bednar
Marketing Director
pam.bednar@pacelabs.com
612-297-0651
Brooke Schwartzel
Brand & Communications Manager
brooke.schwartzel@pacelabs.com
612-656-2241
SOURCE: Pace® Analytical
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/business-and-professional-services/pace-life-sciences-achieves-fourth-consecutive-positive-fda-insp-1053944
