Toronto, ON – BioPharma Services Inc. (BioPharma) is proud to announce that its Toronto-based Bioanalytical Laboratory has successfully passed its first inspection by the Brazilian regulatory authority, ANVISA. This inspection also included a Health Canada inspector as an observer. The inspection covered a comprehensive review of all laboratory procedures, systems and processes. The positive outcome of the inspection makes BioPharma’s Bioanalytical Laboratory an ANVISA approved facility and confirms that the facility is in compliance with Brazilian GCP regulations.
“The successful outcome of this inspection is the direct result of BioPharma’s ongoing commitment to the highest quality standards and dedication to providing excellent service to our international clients. It is a true testament to BioPharma’s ability to providing excellent services in support of submissions to various international regulatory authorities including FDA, EMA, Health Canada and ANVISA.” stated Renzo DiCarlo, CEO, BioPharma Services Inc.
Andjica Tasic, Sr. Director of Quality Assurance and Regulatory Affairs at BioPharma stated: “This was a rigorous three-day inspection at the end of which ANVISA inspectors concluded that our laboratory processes, systems and practices comply with ANVISA regulatory requirements.”
“This is a great milestone for BioPharma’s growth, and we are very proud to be recognized by the Brazilian authorities in addition to past audits by the U.S.A. FDA, UK MHRA and Standards Council of Canada.” said Dr. Fethi Trabelsi, Chief Scientific Officer at BioPharma.
About BioPharma Services Inc.
BioPharma Services Inc. is a Full-Service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide. The company has clinical facilities both in the U.S.A. and in Canada with a total bed capacity of 300 with access to healthy volunteers, special populations and patients. Headquartered in Toronto, Canada, Bio Pharma’s services and capabilities also include support services such as GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Bioanalysis, Biostatistical analysis, Medical Writing and Data Management.
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