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:
- California Clinical Laboratory License ID: COS 00800918
- Clinical Laboratory Improvement Amendments (CLIA) certificate ID : 36D1100176
- Maryland Department of Health, Office of Health Care Quality Medical Laboratory Permit
- New York State Department of Health Clinical Laboratory Permit
- State of Rhode Island and Providence Plantations Department of Health Clinical Laboratory License Number: LCO01323
- State of Pennsylvania Department of Health Clinical Laboratory Permit