Pace Life Sciences has completed a US FDA inspection of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina.

Pace Life Sciences has completed a US Food and Drug Administration (FDA) inspection of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina, with the company reporting a compliant outcome.

The inspection covered the facility’s analytical operations and marks another successful FDA inspection across Pace Life Sciences’ analytical network, according to the company.

The North Carolina site provides analytical services supporting drug development and manufacturing, including storage and stability testing, extractables and leachables testing, analytical method development and validation, and organic spectroscopy.

The facility supports testing across container closure systems and manufacturing materials, as well as the characterisation, quantitation and identification of small and large molecules.

FDA inspections of laboratories and manufacturing facilities are an important part of the regulatory oversight of pharmaceutical and biopharmaceutical supply chains. For organisations providing contract analytical and development services, inspection outcomes can also be relevant to pharmaceutical companies outsourcing testing and other activities during drug development and manufacturing.

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.”

Forcellini added that the inspection outcome reinforced the company’s focus on quality and data integrity across its analytical operations.

Pace Life Sciences provides contract development and manufacturing organisation (CDMO) and contract research services to pharmaceutical, biopharmaceutical and gene therapy companies. Its services include analytical testing, CMC development, clinical trial materials manufacturing, regulatory compliance, consulting and facility support.

The company operates a network of GMP analytical testing laboratories and manufacturing support service centres across the US.

The inspection outcome provides further regulatory reassurance for companies using Pace’s analytical services as they progress drug development and manufacturing programmes.