BECRO Ltd was inspected by US FDA, recently, and the outcome of the inspection was positive:
“No regulatory violations were found during the inspection.”
The FDA conducted this inspection to ensure that data and information submitted to FDA by BECRO are scientifically valid and reliable.
Another objective at the inspection was to ensure that the rights, welfare, and safety of research subjects are protected during the study of an investigational product.
This inspection was conducted by FDA to determine whether the activities and procedures of BECRO complied with 21 CFR Part 320 – Bioavailability and Bioequivalence (BE).
Note that BECRO was one of the very few overseas CROs inspected by US FDA.
BECRO will continue to provide high quality services to our Sponsors in conducting Bioequivalence studies with Clinical and Pharmacokinetic Endpoints.