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.
Avance Biosciences also provides regulatory submission level genomic services in compliance with Good Laboratory Practice Standards required by US Environmental Protection Agency 40 CFR Part 160.
Only approved SOPs/controlled documents are followed during the course of a study.
During a study, at least one in-process or laboratory inspection will be conducted. The study file, data, and final report will be audited by our Quality Assurance Unit prior to issuance of the final report. A Quality Assurance statement will be issued with the final report.