US-based GMP analytical testing laboratory and CDMO, Pace Life Sciences, has passed a US 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, according to the company, which it says ‘reinforces the organisation’s commitment to quality and compliance’.
Lou Forcellini, head of quality assurance at Pace Life Sciences said: “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.”
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.
