Analytical and Bioanalytical Solutions
Empowering Drug Development and Manufacturing
Analytical and Bioanalytical Solutions
Empowering Drug Development and Manufacturing
Welcome to Avance Biosciences
Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development.
Welcome to
Avance Biosciences
Avance Biosciences is a leading CRO and CTO providing CGMP and GLP-compliant assay development, assay validation, and sample testing services to support drug development and manufacturing activities for our clients world-wide.
Our Quality System
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 and other international regulatory agencies.
Our Quality System
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 and other international regulatory agencies.
Cutting Edge Science
Avance Biosciences’ CGMP/GLP compliant analytical and bioanalytical methods make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, ELISA, MSD, Flow Cytometry, and more.
Dedication To Quality
The Avance Biosciences team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, and other international regulatory agencies.
Extensive Experience
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 300 pharmaceutical and biotechnology companies and organizations throughout the world.
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
Avance Biosciences’ CGMP/GLP compliant analytical and bioanalytical methods make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, ELISA, MSD, Flow Cytometry, and more.
Dedication To Quality
The Avance Biosciences team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, and other international regulatory agencies.
Extensive Experience
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 300 pharmaceutical and biotechnology companies and organizations throughout the world.
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.
Your Trusted Partner for
Analytical and Bioanalytical Solutions
Our leading scientists have designed and completed hundreds of analytical projects under CGMP/GLP regulations for the FDA, EPA, as well as European and other international regulatory agencies. This team has extensive knowledge and experience working with scientists, QA/QC professionals and project managers from over 300 pharmaceutical and biotechnology companies and organizations around the world.
CMC Support
Avance Biosciences is a leading Contract Testing Organization (CTO) with extensive experience supporting quality control testing for manufacturing of biologics, cell and gene therapies, and viral and non-viral vaccines. Our team has a track record of providing innovative solutions to our clients world-wide for their analytical needs, supporting identity, purity, stability, potency, and other characterization tests with state-of-the-art analytical technologies.
Preclinical Study Support
With our expertise and extensive experience in the DNA, RNA, and protein quantitation in biological samples, Avance Biosciences offers comprehensive preclinical research designed to study PK/PD properties of various therapeutic drugs. Our custom-designed GLP compliant preclinical testing technologies offer a powerful tool to address the safety and efficacy concerns and satisfy the requirements for regulatory agencies worldwide.
Clinical Study Support
At Avance Biosciences, we excel in supporting clinical trials with our bioanalytical assay development and validation expertise. Leveraging our experience with advanced technologies, our team is dedicated to providing precise and reliable analytical methods to ensure the accuracy and integrity of clinical trial data, meeting the highest industry standards.
Diagnostic Assay Development Support
It is critical for diagnostic device makers to validate their assays for regulatory submissions. Avance Biosciences offers a series of “Gold Standard” methods, such as Sanger sequencing and real-time PCR, that are often required by regulatory agencies for diagnostic test validation. We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.
Your Trusted Partner for Analytical and Bioanalytical Solutions
Our leading scientists have designed and completed hundreds of analytical projects under CGMP/GLP regulations for the FDA, EPA, as well as European and other international regulatory agencies. This team has extensive knowledge and experience working with scientists, QA/QC professionals and project managers from over 300 pharmaceutical and biotechnology companies and organizations around the world.
CMC Support
Avance Biosciences is a leading Contract Testing Organization (CTO) with extensive experience supporting quality control testing for manufacturing of biologics, cell and gene therapies, and viral and non-viral vaccines. Our team has a track record of providing innovative solutions to our clients world-wide for their analytical needs, supporting identity, purity, stability, potency, and other characterization tests with state-of-the-art analytical technologies.
Preclinical Study Support
With our expertise and extensive experience in the DNA, RNA, and protein quantitation in biological samples, Avance Biosciences offers comprehensive preclinical research designed to study PK/PD properties of various therapeutic drugs. Our custom-designed GLP compliant preclinical testing technologies offer a powerful tool to address the safety and efficacy concerns and satisfy the requirements for regulatory agencies worldwide.
Clinical Study Support
At Avance Biosciences, we excel in supporting clinical trials with our bioanalytical assay development and validation expertise. Leveraging our experience with advanced technologies, our team is dedicated to providing precise and reliable analytical methods to ensure the accuracy and integrity of clinical trial data, meeting the highest industry standards.
Diagnostic Assay Development Support
It is critical for diagnostic device makers to validate their assays for regulatory submissions. Avance Biosciences offers a series of “Gold Standard” methods, such as Sanger sequencing and real-time PCR, that are often required by regulatory agencies for diagnostic test validation. We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.
News & Events
FDA Accelerates AI Integration to Transform Drug Review Processes
The FDA is embracing AI to streamline drug reviews, aiming for full implementation by June 2025. Following a successful pilot, this move could fast-track therapy approvals and reduce administrative tasks for scientists...
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!
