- posted in News Release
Toronto, ON, Canada May 6, 2010 – Bio Pharma Services Inc. announced that its Phase I/IIa and Bioequivalence Study Clinical Facilities underwent a successful Good Clinical Practice (GCP) Audit by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on April 16-21, 2010. The UK auditors spent three days at the Toronto, Canada clinical site for the audit. No critical findings were found following the audit.
This successful UK MHRA audit is a testament to the high quality BE study conduct which European pharmaceutical companies regularly expect from Bio Pharma Services Inc. It follows the successful audits conducted by the US FDA on March 2009 which had no FDA483 findings, and by Health Canada which concluded GCP compliance from the audit on November 2008.
Dr. Esmat Dessouki, Bio Pharma’s Chief Executive Officer, Chief Medical Officer and Principal Investigator, commented about the UK audit: “We’ve done it again. Our staff has demonstrated once more how dedicated they are to quality and reliability of conducting clinical trials for our clients.”
About BioPharma Services Inc.
BioPharma Services Inc. is a physician-owned, physician-run, FDA-inspected, UK MHRA-inspected, and Health Canada-inspected Canadian Contract Research Organization (CRO) which specializes in the conduct of Bioequivalence (BE) Studies for generic pharmaceutical companies, and Phase I/IIa clinical trials for innovative pharmaceutical companies from US, Canada, Australia and Europe. The company currently has a modern 158-bed clinical facility based in Toronto, Canada. It is privately held, and it is headquartered in Toronto, Canada.
For more information regarding this release, please contact Ms. Lorelei Lutter at llutter[at]biopharmaservices.ca