Good Laboratory Practice (GLP) services from Azenta Life Sciences, formerly 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 in addition to following GCP and GMP guidelines (as applicable). 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.
Standalone Sanger sequencing services are also offered at the GLP-compliant level. For more information, please email regulatory@azenta.com
Azenta provides both electronic and hard-bound reports for easy incorporation into regulatory submission files.
Components of customized final reports and data packages from Azenta may include, but are not limited to: