To support pre-clinical and clinical regulatory submissions, GENEWIZ has established Good Laboratory Practices (GLP) and Clinical Laboratory Improvement Amendments (CLIA)-compliant workflows for ensuring accurate and consistent sequencing results.
Our clinical lab is CLIA certified by The Centers for Medicare & Medicaid Services (CMS) and accredited by the College of American Pathologists (CAP) for clinical NGS and Sanger sequencing, and we are routinely inspected by CAP for accreditation renewal. Our commitment to providing reliable, cost-effective services and high-quality results remain paramount for our CLIA and GLP service portfolio. We treat all customer information, study-related data, and intellectual property, with the same degree of care and security that we do for our own. This allows our customers at both top-tier pharmaceutical companies and biotechnology start-ups the flexibility to utilize our regulatory services while trusting in our commitment to quality and communication.
Our GLP-compliant services are specifically designed to support FDA and EPA submissions, and the GLP laboratory has been audited by FDA. For more information about our GLP services, or to request an audit, please visit our GLP Services section.