Bio Pharma Services Inc. Successfully Completes its 2nd UK MHRA Audit of Its Clinical Site and Co-Located Bioanalytical Laboratory in Toronto
- posted in News Release
Toronto, ON, Canada April 18, 2013 – Bio Pharma Services Inc. announced today that its Toronto-based clinical site for Phase I/IIa clinical trials and bioequivalence studies and its co-located bioanalytical laboratory successfully completed an audit by the UK MHRA. The audit was conducted as a Good Clinical Practice (GCP) Inspection. This audit also included a Health Canada inspector as an observer. No critical or major findings were cited by the UK MHRA inspectors or the Health Canada inspector. The audit covered the review of several studies, and general processes and systems inspection. The outcome of the Audit was positive for Bio Pharma Services Inc.
In August 2012 and March 2009, Bio Pharma Services Inc. also successfully completed two US FDA audits without any findings.
“At BioPharma Services, we strive to exceed Good Clinical Practices and set the bar high on quality, science and operational execution when conducting bioanalytical lab testing and clinical work at our GCP-compliant facilities. We are proud that esteemed governmental institutions like the UK MHRA and Health Canada recognize our commitment to excellent quality assurance and compliance in bioanalytical testing and early stage clinical research,” cited Mr. Renzo DiCarlo, CEO of BioPharma 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 Phase I/IIa clinical trials and bioanalysis for innovative pharmaceutical, biotech and medical device companies from US, Canada, Australia and Europe. The company currently has a modern 174-bed clinical facility and a co-located bioanalytical laboratory in Toronto, Canada. The company is privately held, and it is headquartered in Toronto, Canada.
For more information
regarding this release, please contact Ms. Lorelei Lutter at llutter@biopharmaservices.ca.
Bio Pharma Services Inc. Successfully Completes its 3rd FDA Audit Without Any Findings
- posted in News Release
Toronto, ON, Canada August 10, 2012 – Bio Pharma Services Inc. announced today that its clinical site for Phase I/IIa clinical trials and bioequivalence studies successfully completed an audit by the US’ Food and Drug Administration (FDA). The audit was conducted as part of a routine Pre-Approval Inspection. No FDA 483 was issued by the FDA auditor. The audit focused primarily on one pivotal study. The outcome of the Audit was positive for Bio Pharma Services Inc. since the FDA completed the week-long audit without any findings. In March 2009, Bio Pharma Services Inc. also successfully completed a US FDA audit without any findings. This latest audit is now the second consecutive FDA audit of BioPharma without any findings, highlighting the continued focus of BioPharma to perform at the highest quality standards.
Regarding this very successful audit, Mr. Renzo DiCarlo, CEO, stated, “This positive outcome is a direct result of BioPharma’s diligence and quest for excellence when delivering high quality services to our clients and subjects. Our quality culture permeates throughout all of our projects, from clinical conduct, bioanalytical testing, biopharmaceutical analysis, to data management and report writing.”
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 174-bed clinical facility based inToronto,Canada, and a newly-opened bioanalytical laboratory at the same facility. It is privately held, and it is headquartered inToronto,Canada.
For more information regarding this release, please contact Ms. Lorelei Lutter at llutter@biopharmaservices.ca
Bio Pharma Services Inc. Announces Dr. Fethi Trabelsi as VP Scientific Affairs
- posted in News Release
Toronto, ON, Canada, February 28, 2012 – Bio Pharma Services Inc. (BPSI) announced that Dr. Fethi Trabelsi has joined the company in the role of Vice-President of Scientific Affairs starting Feb 27th, 2012. Dr. Trabelsi brings to BioPharma extensive experience and knowledge in the Bioequivalence and Phase I fields. He is well known and highly regarded in the industry and has been in various management roles in the last 15 years. Previous to BioPharma, Dr. Trabelsi had senior management posts at Pharmanet, Anapharm and MDS Pharma in Quebec, Canada.
Bio Pharma Services Inc. Announces New CEO
- posted in News Release
Toronto, ON, Canada September 28, 2011 – Bio Pharma Services Inc. (BPSI) announced that Mr. Renzo DiCarlo has been promoted to Chief Executive Officer effective immediately. Mr. DiCarlo joined BioPharma in February 2011 as Chief Operating Officer.
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