SAN GERMÁN, Puerto Rico, March 28, 2024 (Newswire.com)
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Pace® Life Sciences, LLC, a full-service FDA-registered central laboratory and contract development and manufacturing organization (CDMO), announced the receipt of an overall positive review from The Food & Drug Administration (FDA), following a three-day general inspection of the company’s quality systems and client data delivery processes at its laboratory in San German, Puerto Rico.
Lou Forcellini, Head of Quality Assurance at Pace® Life Sciences, shares, “The success of this inspection is a positive reflection of our entire laboratory network, including the strength of our quality leadership, the team of highly experienced laboratory professionals, and our commitment to data integrity and compliance through robust quality systems. More than five years have passed since our previous US FDA inspection in San German, and we have remained diligent. We host more than 60 client audits each year that challenge our system and ensure we are robust and up to date with current quality expectations.”
The operation in Puerto Rico includes a team of more than 60 fully bilingual chemists and microbiologists who have decades of proven expertise and a strong track record supporting pharmaceutical and medical device clients from around the world. In 2023, this laboratory achieved an average turnaround time of 10 working days for client projects, a remarkable industry benchmark. With over 22,000 square feet of chemistry and microbiology laboratory space, this location is registered with both the US FDA and the US Drug Enforcement Agency (DEA). Primary services offered at this laboratory include:
- Chemistry & Microbiology Laboratory Testing
- Raw Material Clearance Programs
- In-Process & Finished Product Testing
- ICH Stability Programs
- Facility Environmental Monitoring Programs
- Cleaning Verification/Disinfectant Efficacy Studies
Pace® is a portfolio company of Leonard Green & Partners and Los Angeles-based Aurora Capital Partners.
ABOUT PACE® LIFE SCIENCES
Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of GMP analytical testing laboratories and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. More at pacelifesciences.com.
ABOUT PACE®
Pace® makes the world a safer, healthier place. Pace® people are committed to advancing the science of the pharmaceutical and biotechnology industries in our Life sciences laboratories and supporting businesses, industries, consulting firms, government agencies, and more in our Analytical Services Laboratories. Pace® offers local-level service backed by a national laboratory network. For customers with in-house labs, Pace® provides a range of professional services to keep their operations moving forward. Pace® people work in partnership with customers by providing the service, science and data they need to make critical decisions that benefit us all.
Source: Pace® Life Sciences
