Successful FDA Audit of Biotrial Bioanalytical Services Projects
January 9th, 2015 – Laval, Quebec, Canada
For two weeks at the beginning of December, Biotrial Bioanalytical Services (BBS) welcomed the FDA for a thorough audit of several projects managed at our facilities. Also audited were SOPs and pertinent records and documents related to these studies as well as general facility documents.
Our interactions with the US regulator provided us with precious feedback on our work performed and guidance for future projects. BBS is extremely pleased to have had the high quality of our work confirmed by the FDA for the second time in as many years, as no form 483 was issued at the end of the review.
BBS offers quality services for all Bioanalytical projects, whether Preclinical or Clinical – including First-in-Human, Bioequivalence, Bioavailability or Interaction protocols. Our experts are available to assist sponsors in developing even the most challenging assays, for both large and small molecules and through all stages of development.