Welcome to Avance Biosciences™

Avance Biosciences™ is a leading CRO providing CGMP and GLP-compliant assay development, assay validation, and sample testing services to support biological drug development and manufacturing activities world-wide.

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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Partner

Your Trusted Partner for
Advanced Biological Assay Solutions

Our leading scientists have designed and completed hundreds of analysis projects under CGMP/GLP regulations for the FDA, EPA, as well as European and Japanese regulatory agencies. This 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.

Quality

OUR QUALITY STATEMENT

Our established quality system is based on the requirements of Good Laboratory Practices, current Good Manufacturing Practices, and Quality System Regulation as promulgated by the U.S. Food and Drug Administration 21 CFR Part 58, 21 CFR Parts 210, 211, and 820 respectively, and by European, Japan, and other international regulatory agencies.

MEET OUR MANAGMENT

Our experienced technical and quality staff have worked together for more than two decades offering GLP/GMP compliant molecular biology and microbiology assays to support regulatory submissions.

XUENING (JAMES) HUANG, PhDGeneral Manager, Co-founder
Dr. Huang has extensive management experiences in the biotechnology service industry. Before he joined Avance Biosciences™, he held senior management positions in several biotechnology service companies…
DAVID WALL, PhDVP of Quality, Co-founder
Dr. Wall brings more than 20 years of experience in the molecular biology and microbiology industry and has a profound knowledge of both GxP quality compliance and the biological sciences…
LI (KIMBERLY) LI, PhDVP of Project Management, Co-founder
Dr. Li has extensive experience in the molecular biology industry and possesses strong technical leadership in DNA sequencing, qPCR, Southern Blot, and other molecular biological methods…

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