Diagnostic Assay Validation

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.


Avance Bioscience team has more than two decades of experience supporting validation of diagnostic tests.  Our team successfully helped many pharmaceutical and diagnostic companies to validate their assays based on ICH guidelines.

  • Extensive experience with assay validation
  • Expertise in various genomic technologies
  • Professional at project management
  • Dedicated to meeting client’s deadlines
  • Compliance with GLP, GMP, and ICH guidelines

When you partner with Avance Biosciences for your assay development and validation, we give you undivided attention, share our experience and knowledge in assay validation, and work with you closely to meet your submission timelines. Contact¬†Avance¬†Biosciences’ experienced technical team to discuss your next assay validation project.


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