BioPharma Services announces successful completion of Austrian Regulatory Agency (AGES) Audit
BioPharma Services Inc. is happy to report the successful completion of another regulatory industry audit. During the week of September 12, 2022, BioPharma was host to a multi-agency inspection.
Leading the inspection were inspectors from the Austrian Agency for Health and Food Safety (AGES) with co-inspectors from the Danish Medicines Agency (DKMA) and the Dutch Medicines Evaluation Board (CBG). Also in attendance was an inspector, acting as an observer, from Health Canada.
The intensive Clinical and Bioanalytical Lab inspection examined two studies in addition to BioPharma’s rigorous Standard Operating Procedures at all levels, and the inspection concluded without any major observations.
Jo Ann Di Sensi, Vice President, Global Quality Assurance & Privacy Officer was on hand to lead the inspection and noted, “An inspection team of this magnitude can be a bit daunting simply because of the number of Inspectors present, but the BioPharma team was “inspection ready”, completely confident in the execution of their policies and procedures, and early phase study execution.”
Anna Taylor, Managing Director, commented, “The exceptional level of skill and professionalism exhibited by our team daily was clearly evident during the audit. Having over 35 agency inspections to date, without major observations, is a real win for the team and clearly shows the quality of service we offer for Phase 1 drug development programs”. Review BioPharma’s full Regulatory History Here.
About BioPharma Services Inc.
BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma Services has clinical research facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing. For more information about BioPharma Services, please contact Ms. Anna Taylor, Managing Director at ataylor@biopharmaservices.com
