BioPharma Services Inc. Scores Another Perfect US FDA Audit
Toronto, ON – BioPharma Services Inc. (BioPharma) is proud to announce that its Toronto-based clinical and bioanalytical site for Phase I/IIa clinical trials and bioequivalence studies has successfully completed an audit by the U.S. Food and Drug Administration (FDA). This was BioPharma’s 4th inspection by the FDA (2008, 2009, 2012 and 2015) and the 1st inspection of the bioanalytical laboratory unit. The audit was conducted from June 1st to June 5th as a Pre-Approval Inspection for ANDAs submitted. The inspection confirmed that the clinical and bioanalytical facilities were in compliance with the principles and guidelines of GCP. No Form 483 observations were issued. This is BioPharma’s 3rd consecutive FDA inspection without Form 483 observations.
The successful outcome of the audit is the result of BioPharma’s unswerving commitment to the highest quality standards. It is supported by a growing list of additional regulatory inspections, including GCP inspections by the UK MHRA (2010, 2013) and, more recently, an OECD GLP Certification by the Standards Council of Canada in February, 2015. This recent FDA audit is another milestone achievement for BioPharma.
“I am thrilled and proud of our people and company for achieving a flawless FDA inspection and for maintaining top notch quality in our bioanalytical lab and clinics. Great quality is good business and our team continues to excel on both fronts,” remarked Mr. Renzo DiCarlo, CEO of BioPharma Services.
About BioPharma Services Inc.
BioPharma Services Inc. is a fullservice Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Medical Writing and Data Management.
Main Telephone: +1 844 747 8484
Email: info@biopharmaservices.com
Website: www.biopharmaservices.com
Contact Information:
Ms. Anna Taylor, Executive Vice President, Business Development, BioPharma Services, Inc.
ataylor@biopharmaservices.com
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What is the length of a study and do I have to complete all the visits?
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Privacy
We respect and value the privacy of our volunteers. View our Privacy and Cookie Policy here.