Notrox Research has announced successful completion of a US Food and Drug Administration (FDA) audit conducted as a part of the routine Bioequivalent Clinical Bioresearch Monitoring (BIMO) inspection programme.
The FDA inspector commented that all documents were found to be in compliance with good clinical practice (GCP) and good laboratory practice (GLP), and overall subject safety and quality aspects were found to meet regulators expectations.
Notrox Research noted it will communicate to you after it receives the established inspection report (EIR) from the FDA agencies.
The company believes these accomplishments are testimony of its overall commitment to quality and international regulatory compliance in the clinical research domain. Notrox Research thanks you all in continued support and patronage.
The National Expert / Bioresearch Monitoring inspection lasted for four days as initially planned, starting on 4 December and concluding on the 7 December 2017.
Notrox Research is very proud of the results achieved during this flawless FDA inspection.
You can meet the company at DCAT from 19 March to 22 March in New York City, and at CPhI from 24 April to 26 April in Philadelphia.