GLP-Compliant Confirmatory Sequencing

The right assay means the right product: Complete Solution Starting from Nucleic Acid Extraction Services


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Regulated Sequencing

GENEWIZ can characterize your samples using GLP-compliant methods according to FDA or EPA regulations. Simply provide your mammalian, insect, prokaryotic cell bank, or your virus master stock and GENEWIZ will design, develop, and/or optimize the assays to verify the bank’s identity and stability. GENEWIZ’s experienced scientists and Quality Assurance Unit ensure that your assays are processed and reported according to applicable regulatory standards.



Features & Benefits

Complete Solution Starting from Nucleic Acid Extraction Services

Nucleic acid extraction services
Identity/stability assay development
Dedicated Study Director
Detailed final report; includes a description of the methods, list of SOPs, raw data, and detailed results
State-of-the-Art, Dedicated GLP Laboratories
FDA and EPA GLP-compliant, reliable services
Controlled facility, sample, personnel, process, and documents
Special handling for sensitive assays
Proprietary Protocols
Complete sequencing, even in regions with high-GC content
≥4x double-strand coverage
Established Quality Management System
Quality Assurance Unit oversight
GENEWIZ is available for audits
Outsource to the Industry Leader in Sanger Sequencing
Developed and documented processes
Qualified instruments
Trained personnel
Dedicated, state-of-the-art regulatory laboratory
Thorough quality assurance program saves you time, reagents,  paperwork
Superior Support
Dedicated Study Director ensures a single point of contact
Expert technical support, and consistent, transparent communication

Sequence Confirmation Process


  • Assay Design



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  • Sample
    Processing


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  • Data Analysis & Reporting


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Primers and conditions are optimized to the target region(s) of interest. Study Protocol and SOPs are utilized in compliance with GLP regulations.
Sample preparation, amplification, and sequencing of target region(s). GENEWIZ network of quality oversight ensures compliance with GLP regulations.
Data quality review and detailed Study Report outlining methods used, results, compliance statement, and quality oversight inspection dates, results in Quality Assurance of each Study according to GLP regulations.

GLP-COMPLIANT SANGER SEQUENCING

Standalone Sanger Sequencing services are also available at the GLP-compliant level.

For more information, please email regulatory@genewiz.com.

 


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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