CGMP – Current good manufacturing practices – are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of pharmaceutical products, and medical devices. GMP regulations are enforced by the US FDA (21 CFR Parts 210/211), OECD, European Commission, or Japanese Agency.
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!
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.
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.
Avance Biosciences’ GLP/GMP 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.