GENEWIZ 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 GENEWIZ can design, develop, and optimize your assays. GENEWIZ’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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