Good Laboratory Practice (GLP) services from GENEWIZ are designed to be compliant with US FDA (21 CFR Part 58) and US EPA (40 CFR Part 160) regulations to support pre-marketing authorizations. Our commitment to providing reliable, cost-effective services and high-quality results remain paramount in our GLP-compliant services. 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.
GENEWIZ provides both electronic and hard-bound reports for easy incorporation into regulatory submission files.
Components of customized final reports and data packages from GENEWIZ may include, but are not limited to:
Standalone Sanger sequencing services are also offered at the GLP-compliant level. For more information, please email regulatory@genewiz.com