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.

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.

Quality

AVANCE IS COMMITTED TO QUALITY

Our industry-leading quality system is designed and maintained to support drug and device research and development, GLP pre-clinical trials, cGMP biomanufacturing, and clinical trials.

Avance Biosciences provides biological testing services to support regulatory submission for clients around the world. These services are conducted under the requirements of Good Laboratory Practices and Current Good Manufacturing Practices as promulgated by the U.S. Food and Drug Administration 21 CFR Part 58 and 21 CFR Part 210 and 211, as well as Good Manufacturing Practice according to ICH Q7, where applicable to the laboratory services provided.

We welcome current and potential clients to conduct on-site quality and technical audits. Clients may contact our Quality Unit to schedule a visit.

Have questions?

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.

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Ready to get started?

Give us a little background on your needs and the goals of your project, and we’ll send a preliminary quote including: tasks, deliverables and a no-obligation cost estimate.

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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

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!

Partner

Dedication to Quality

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.

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Extensive Experience

Open Communication

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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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.

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Cutting Edge Science

Open Communication

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.

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