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.
Sanger sequencing is utilized as the “Gold Standard” to validate nucleic acid based diagnostic tools/devices for Premarket Approval (PMA) or 510K clearances. Avance Biosciences’ DNA Sequencing services are performed in compliance with GLP and CGMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
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.
Our Customers Say…
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences’ services to colleagues and friends.
Senior Scientist, Singapore