GLP-Compliant SNP/Mutation Analysis

 

GENEWIZ SNP/Mutation Analysis is designed to follow Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) as applicable to our services, and Good Clinical Practice (GCP) guidelines. Validate diagnostic assays with confidence and detect genetic mutations accurately, empowering you to achieve clinical success.

 

GLP-Compliant SNP/Mutation Analysis

The right assay means the right drug: Confirm diagnostic assays & detect genetics mutations with GENEWIZ



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REGULATORY SNP DETECTION AND MUTATION ANALYSIS

Azenta can sequence and analyze your clinical trial samples or confirm your diagnostic assay results according to FDA and EPA GLP standards. Simply provide SNP IDs, genes, or sequences of interest and Azenta can design, develop, and optimize your assays. Azenta’s experienced scientists and Quality Assurance Unit will ensure your assays are processed and reported according to the applicable regulatory standards.

 

 

DIAGNOSTIC KIT AND MEDICAL DEVICE ASSAY VALIDATION

Assay validation services for diagnostic kit and medical device 510k and PMA submissions are available at the GLP-compliant level.
For more information, please email regulatory@azenta.com.




Ensure Complete Plasmid Validation on Your First Attempt

with Oxford Nanopore Sequencing

 

 

Features & Benefits

Complete Solution

  • Nucleic acid extraction services
  • SNP (single nucleotide polymorphisms) and mutation assay development
  • Dedicated Study Director
  • Detailed Study Report including description of 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
  • Follows GMP (as applicable to our services) and GCP guidelines

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 save you time, reagents, paperwork

Established Quality Management System

  • Quality Assurance Unit oversight
  • Azenta is available for audits

Proprietary Protocols

  • Complete sequencing, even in regions with high GC content

Superior Support

  • Dedicated Study Director ensures a single point of contact
  • Expert technical support
  • Consistent, transparent communication

GLP-Compliant SNP/Mutation Analysis Process


  • Assay Design



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  • Sample
    Processing


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  • Data Analysis & Reporting


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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.

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.

Email | Phone (1-877-436-3949, Ext. 3350)