Company confirms high standards for data integrity and quality systems
MINNEAPOLIS, MINNESOTA / ACCESS Newswire / May 20, 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, announced today a successful Pre-Approval Inspection (PAI) from The Food & Drug Administration (FDA) highlighting company's commitment to reliable and accurate data.
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Lou Forcellini, Head of Quality Assurance at Pace® Life Sciences, stated, "The recent achievement for our Lebanon, NJ laboratory emphasizes our quality expertise and commitment to data integrity and compliance through our quality systems. The successful PAI demonstrates our ability to support customer programs from first-in-man studies to FDA approval, with flexibility to meet client needs." The Lebanon site, formerly Whitehouse Analytical Laboratories, was acquired by Pace® from Curia in 2024 and specializes in Container Closure Integrity Testing (CCIT), drug delivery physical testing, and package distribution testing.
"Our commitment to supporting clients from early-stage research and development to commercialization begins with ensuring quality data and testing," noted Dawn Von Rohr, President, Pace® Life Sciences. "The successful PAI recognition by the FDA validates the talent, expertise, and experience our team has with ensuring data integrity and regulatory compliance that makes us a trusted partner of top pharmaceutical companies." Pace® provides commercial release and stability testing for raw materials, active pharmaceutical ingredients (APIs), finished pharmaceuticals, and biologics, along with regulatory compliance, quality assurance, and process optimization support to the biotech and pharmaceutical industries.
In 2024, the FDA conducted an inspection of operations at the Pace® Life Sciences laboratories located in Oakdale, MN, and San Germán, Puerto Rico, with favorable outcomes from the harmonized quality systems, further demonstrating the company's continuous dedication to providing the highest quality results to clients.
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 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. More at PACELIFESCIENCES.com.
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 through our Analytical Services laboratories. Pace® offers local-level service backed by a national laboratory network. For clients with in-house labs, Pace® provides a range of professional services to keep their operations moving forward. Pace® people work in partnership with clients by providing the service, science, and the data they need to make critical decisions that benefit us all. More at PACELABS.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-announces-successful-pre-approval-inspection-1029216
