The CDMO Pace Life Sciences has passed an inspection of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina, by the US Food and Drug Administration (FDA).
The Research Triangle Park facility provides comprehensive analytical support throughout the drug development and manufacturing lifecycle, including the following:
- 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 characterisation, quantitation and identification of small and large molecules.
The successful inspection, the firm said, reinforces its "long-standing commitment to quality, regulatory compliance and data integrity" at its analytical operation sites and adds to its proven track record of "consistent high quality."
"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.
