Pace Life Sciences Passes FDA Pre-Approval Inspection, Strengthening Contract Manufacturing Capabilities
Key Insights
Pace Life Sciences (search) successfully completed a Pre-Approval Inspection (PAI) from the FDA at its Lebanon, New Jersey laboratory, confirming high standards for data integrity and quality systems.
The Lebanon facility, acquired from Curia in 2024, specializes in Container Closure Integrity Testing (CCIT), drug delivery physical testing, and package distribution testing for pharmaceutical clients.
The successful inspection demonstrates the company's ability to support pharmaceutical programs from first-in-man studies through FDA approval, reinforcing its position as a trusted CRDMO partner.
Pace Life Sciences (search), a U.S.-based contract research, development and manufacturing organization (CRDMO), announced it has successfully completed a Pre-Approval Inspection (PAI) from the Food and Drug Administration at its Lebanon, New Jersey facility. The inspection validates the company's commitment to data integrity and quality systems across its pharmaceutical testing operations.
Quality Standards Validated
Lou Forcellini, Head of Quality Assurance at Pace Life Sciences (search), emphasized the significance of the achievement: "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 known as Whitehouse Analytical Laboratories, was acquired by Pace from Curia in 2024. The facility specializes in Container Closure Integrity Testing (CCIT), drug delivery physical testing, and package distribution testing, providing critical services for pharmaceutical product development and commercialization.
Comprehensive Service Portfolio
Dawn Von Rohr, President of Pace Life Sciences (search), highlighted the company's broad capabilities: "Our commitment to supporting clients from early-stage research and development to commercialization begins with ensuring quality data and testing. 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. The company also offers regulatory compliance, quality assurance, and process optimization support to the biotech and pharmaceutical industries.
Network-Wide Excellence
The Lebanon facility's successful inspection builds on Pace's track record of regulatory compliance. In 2024, the FDA conducted inspections of operations at Pace Life Sciences (search) laboratories located in Oakdale, Minnesota, and San Germán, Puerto Rico, with favorable outcomes from the harmonized quality systems. These results demonstrate the company's continuous dedication to providing high-quality results to clients across its network.
Strategic Positioning
As a full-service FDA-registered GMP Analytical Testing laboratory and CRDMO, Pace Life Sciences (search) provides contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. The company operates a network of CDMO sites consisting of GMP analytical testing laboratories and manufacturing support service centers.
Pace is a portfolio company of Leonard Green & Partners (search) and Los Angeles-based Aurora Capital Partners (search), providing the financial backing to support continued investment in state-of-the-art development and manufacturing facilities.