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.

Cross Validation - Sanger Sequencing

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/GMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.

Cross Validation - Real-time PCR

Our GLP/GMP qPCR services are established to support the identity and safety test of GMP 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™.

Custom Assay Development

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.

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!

Partner

Dedication to Quality

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.

Extensive Experience

Extensive Experience

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.

Open Communication

Open Communication

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

Open Communication

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.