Confidence Through Compliance, Collaboration, and Communication

Highly Reliable, Effortless Collaboration for FDA and EPA Applications



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GLP-COMPLIANT SERVICES

 

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.

 

Deliverables

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:


Description of all materials and procedures
Contig assemblies and graphic contig overview
Consensus sequences
Raw sequence data with accompanying quality scores
Detailed mutation report, where applicable
Certificate of Analysis (COA), where applicable
GLP Compliance Statement signed by Study Director
QAU Statement with inspection dates

Features & Benefits

A dedicated Study Director for proactive, transparent communication throughout your entire study (consultation through completion).
Rigorous planning, proven technology, and an outstanding quality management system give you confidence that your project will meet FDA and EPA regulations.
Project collaboration with scientific and quality assurance teams that includes a project-specific Study Protocol (scope of work, SOPs, project requirements, and project deliverables).
Study Director-approved final Study Report showing all work performed along with the final results in multiple views as well as details highlighting Quality oversight.
Access to comprehensive solutions spanning sample management, analysis, automation, and informatics, you can have complete confidence that your samples are safe and optimized, and your program has the best chance of success.


Troubleshooting DNA Templates
with Sanger Sequencing

 

 


Featured Services

Plasmid Preparation

Standalone Sanger sequencing services are also offered at the GLP-compliant level. For more information, please email regulatory@azenta.com

Related Research Areas

How to Order

*Samples must arrive at the GENEWIZ New Jersey Laboratory before 10:00 am EST to qualify for Same Day service. Note that direct-sequencing templates are not available for our Same Day service.

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GENEWIZ from Azenta Life Sciences

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