Pace Life Sciences completes FDA inspection in RTP, names new president
Key Takeaways
- FDA inspection: Pace Life Sciences completed a successful FDA inspection at its Analytical Center of Excellence in Research Triangle Park
- New president: Andrew (Andy) Fenny named president of Pace Life Sciences
- Analytical services: The RTP facility has supported pharmaceutical development and analytical science in North Carolina since the 1980s and provides analytical services across the drug development and manufacturing lifecycle
Pace Life Sciences, a division of Pace, a science and technology company, has completed another successful U.S. Food and Drug Administration (FDA) inspection of its Analytical Center of Excellence in Research Triangle Park, North Carolina.
Pace Life Sciences is a GMP analytical testing laboratory and full-service contract research, development and manufacturing organization (CDMO).
“A successful inspection gives pharmaceutical and biotech customers added confidence that we have strong quality systems, robust controls, and a culture of compliance,” said Michele DeRider, Ph.D., senior director and site lead, Pace Life Sciences, RTP. “Our consistent positive inspection history, the latest in June 2026 for a routine General GMP inspection, demonstrates that this commitment is embedded in how we operate every day.”
Pace also recently appointed Andrew (Andy) Fenny as president of Pace Life Sciences. Based in RTP, Fenny will lead all aspects of the division, build collaboration across all eight Pace Life Sciences sites and direct the delivery of the organization’s service capabilities to support customers from early development through clinical supply and commercialization.
“Pace Life Sciences has a strong foundation of scientific expertise, technical talent and customer commitment,” said Fenny. “As life sciences organizations look for partners who can help deliver with speed and accuracy amidst evolving challenges, Pace is well positioned to deliver integrated support so these organizations can move forward with greater confidence and continuity.”
According to the company, Fenny will lead the business into its next phase of strategic growth with a focus on expanding support and capacity for pharmaceutical and biotech clients across the development cycle.
As life sciences organizations look for partners who can help deliver with speed and accuracy amidst evolving challenges, Pace is well positioned to deliver integrated support so these organizations can move forward with greater confidence and continuity.
— Andy Fenny, Etiam quis sodales metus
’Support from drug development to manufacturing
The Pace Life Sciences Analytical Center of Excellence in RTP provides comprehensive analytical support throughout the drug development and manufacturing lifecycle to a broad range of pharmaceutical and biotech companies, from emerging innovators advancing new drug candidates to established companies managing commercial products.
The FDA inspects laboratories like this one to verify compliance with cGMP requirements, data integrity expectations and quality systems. These inspections are risk-based and are intended to ensure that the analytical data used to support pharmaceutical products are reliable and scientifically sound.
The RTP facility’s services include storage and stability testing; extractables and leachables (E&L) testing across container closure systems and manufacturing materials; analytical method development and validation; and organic spectroscopy for characterizing, quantifying and identifying small and large molecules.
“For North Carolina companies, having these capabilities in RTP means access to experienced scientific teams and GMP-compliant analytical services,” said DeRider. “Whether it’s developing and validating analytical methods, conducting stability studies or generating data to support regulatory submissions and commercialization, our goal is to help customers navigate critical development milestones efficiently while maintaining a strong focus on quality and compliance.”
A longstanding analytical legacy
The site has a long history of supporting pharmaceutical development and analytical science in North Carolina. It started in the 1980s as Magellan Laboratories, one of the state’s first contract pharmaceutical development and analytical services companies. The site also played an important role in the early development of E&L testing.
The facility later became part of Catalent and was then acquired by Pace Life Sciences in 2024. Since joining Pace Life Sciences, the company has continued to invest in instrumentation and expanded scientific capabilities.
The site now includes new analytical instrumentation for advanced characterization and analysis, including high-field NMR, high-resolution mass spectrometry, accurate-mass LC/MS and X-ray diffraction. These capabilities enable the lab to perform more detailed chemical and materials characterization and support a broader range of analytical needs for pharmaceutical development.
Water microbiology is a newer service at the facility that supports North Carolina’s growing pharmaceutical manufacturing industry by helping manufacturers meet GMP requirements for controlling microorganisms in pharmaceutical water systems.
“Our investments also extend to our people,” said DeRider. “Being in the heart of North Carolina’s life sciences community gives us access to exceptional scientific talent and allows us to continue building a strong team alongside the pharmaceutical and biotech companies we serve.”