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 quick message with your questions to find out what Avance can do for you.
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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.
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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.
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