Diagnostic Assay Validation
Providing Creative Molecular and Microbiology Solutions for Regulatory Submissions
It is critical for companion diagnostic device makers to validate their assays under GLP or GMP for regulatory submissions. Avance Biosciences offers a series of “Gold Standard” methods that are often required by regulatory agencies for diagnostic test validation or assay validation.
Our GLP/GMP compliant genomic and biological assays make use of the most advanced technologies including next-gen sequencing, ddPCR, Sanger sequencing, real-time PCR, Southern blot, and more. The Avance Biosciences team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies. Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from pharmaceutical and biotechnology companies throughout the world.