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.
Assay validation services for diagnostic kit and medical device 510k and PMA submissions are available at the GLP-compliant level.
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Complete SolutionNucleic acid extraction services
State-of-the-Art, Dedicated GLP LaboratoriesFDA and EPA GLP-compliant, reliable services
Outsource to the Industry Leader in Sanger SequencingDeveloped and documented processes
Established Quality Management SystemQuality Assurance Unit oversight
Proprietary ProtocolsComplete sequencing, even in regions with high GC content
Superior SupportDedicated Study Director ensures a single point of contact