The KCAS Bio – Lyon, France Site Renews Its GLP Compliance Statement, Strengthening Its Support for IND-Enabling Studies Through Bioanalysis and Biomarkers

KCAS Bio today announced that its European site in Lyon, France, has successfully renewed its Statement of Compliance with Good Laboratory Practices (GLP) according to Directive 2004/9/CE (safety tests), confirming the site’s continued ability to deliver GLP-grade bioanalytical methods in support of preclinical studies.

The GLP test facility once again earned a Level of Compliance “A,” reinforcing KCAS Bio’s capability to support critical investigational new drug (IND)-enabling programs. This renewal provides sponsors with continued confidence that their studies are supported by robust, compliant, and regulatory-ready bioanalytical data.

This GLP renewal, combined with the site's ISO 9001:2015 certification, which has been maintained without interruption for more than 15 years, reflects the rigor, reliability, and consistency demonstrated by the scientific teams at the Lyon site in all projects throughout the drug discovery and development continuum.

“Our renewed GLP compliance underscores our unwavering commitment to scientific excellence and regulatory integrity,” said Dr. Mouhssin Oufir, KCAS Bio – Lyon, General Manager and GLP Test Facility Manager (TFM). “For drug development sponsors advancing IND-enabling programs, the quality and credibility of bioanalytical data are critical. Achieving and maintaining a Level ‘A’ compliance status demonstrates that our systems, processes, and people are aligned to deliver the dependable, regulatory-ready data sponsors need to move forward with confidence.”

KCAS Bio’s Lyon site supports Toxicokinetic (TK) studies across a broad range of preclinical species, including mouse, rat, rabbit, dog, minipig, and non-human primates (marmoset and cynomolgus monkey). The site provides bioanalytical expertise across multiple modalities, including large molecules, biologics, small molecules, cell and gene therapies, vaccines, and oligonucleotides.

Through its continued commitment to quality and compliance, KCAS Bio enables sponsors to generate data they can confidently rely on to support sound decision-making throughout both preclinical and clinical development.

Further information:

About KCAS Bio – KCAS Bio is a premier international provider of bioanalytical and laboratory services that provides comprehensive GLP- and GCP-compliant development services from early discovery support through commercial approval and beyond. One of only a select few CROs offering both large and small molecule development with extensive capabilities and expertise, KCAS Bio provides a truly differentiated approach to its clients who are looking for both scientific expertise and excellent customer service. KCAS Bio is headquartered in Olathe, Kansas – the Kansas City, KS metro area, supported by more than 380 employees. Further information can be found at www.KCASBio.com.

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