Lab Licensure
Pathway Diagnostics provides a comprehensive portfolio of biomarker assays to our clients in research and clinical settings. To meet our clients' regulatory needs, we offer a GLP-compliant approach to clinical trials testing in a CLIA-certified laboratory. We are located in Malibu, California, and are licensed for laboratory services by the State of California.
We offer a data storage system designed for compliance with FDA 21 CFR Part 11, Final Rule on Electronic Records and Electronic Signatures. In addition, quality assurance documentation is offered through customized bioanalytical and final study reports that can be provided in support of FDA submissions.
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