- posted in News Release
Toronto, ON, Canada, December 2, 2008 – BioPharma Services Inc. today reported the favourable outcome from an inspection of its facilities performed by HealthCanada’s Health Products and Food Branch Inspectorate, and completed on November 14, 2008.
The inspection was specific to Good Clinical Practices (GCP), and it was carried out under the authority of Section 23 of the Food and Drugs Act to verify compliance with Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” and any other pertinent Regulation of the said Act. An overall rating of “C” was given, meaning no objectionable conditions or practices were observed during the inspection. The inspector audited Bio Pharma’s quality systems, SOPs, as well as a client-specific study.
In February 2008, BioPharma Services Inc. also successfully passed an FDA inspection of its clinical facilities.
“I am very proud to announce that BioPharma Services Inc. has successfully passed the Health Canada audit of its operations. Coupled with being an FDA audited facility speaks volumes of our staff dedication, professionalism and hard work in their conduct of pharmaceutical industry sponsored clinical trials,”” said Dr. Esmat Dessouki, CEO of Bio Pharma Services Inc.
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