Diagnostic Assay Development SupportChris Hebel2019-04-11T12:13:06+00:00
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 cGMP and GLP enacted by the US, European, Japanese, and other international regulatory agencies.
Our cGMP/GLP QPCR services are established to support the identity and safety test of cGMP biologics, the analysis of preclinical and clinical trial samples, and the validation of DNA-based tests and devices for PMA or 510K clearances. Custom QPCR assay design and validation of target specific assays are routinely designed, qualified or validated at Avance Biosciences.
Avance Biosciences is a CRO specialized in QPCR assay development. We offer a broad range of QPCR Assay Development services, including assay design, assay validation, sample testing, and technology transfer under GLP compliance to support drug research and development.
We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a note or give us a call to find out what Avance can do for you.
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
When you partner with Avance Biosciences, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. 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 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 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.
Avance Biosciences’ cGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.