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.
When you partner with Avance Biosciences, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
Dedication to Quality
The Avance Biosciences team is committed to strict adherence to GLP and CGMP 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 over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.
Cutting Edge Science
Avance Biosciences’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.