CTL Contract Laboratory Services Compliance

CTL’s Contract Laboratory Services provide different levels of service depending on the needs of our clients as well as the stage of assay development.

Our contract laboratory follows FDA guidelines for diverse regulations (GCP, GLP), GMP when applicable and is Part 11 compliant. In addition, we follow ICH guidelines, and our laboratory is CLIA/CLEP certified. We specialize in setting up custom Laboratory Developed Tests (LDT) for our clients in accordance with FDA Guidance for Bioanalytical Method Validation.

Certificates and permits: