The Avance Biosciences™ team is committed to strict adherence to CGMP and GLP regulations and guidelines enacted by the US, European, Japanese, and other international regulatory agencies. The Avance Biosciences™ Houston, Texas facility provides regulated and research grade contract molecular biology testing services to pharmaceutical, biotechnology, and other institutions. 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. In addition, Avance Biosciences™ provides genomic services supporting regulatory submission to the US Environmental Protection Agency per 40 CFR Part 160.
Avance Biosciences™’ compliance with these regulations is defined in the Avance Biosciences™ Quality Manual, Quality System Master Plan, and Quality System (QS) Standard Operating Procedures (SOPs).