BioPharma Services Inc (BioPharma) revealed on Monday that it has successful passed World Health Organization (WHO) GCP/GLP/BE assessment and review of its Toronto, Canada site.
The company's Toronto, Canada site was found to be in compliance with WHO Good Clinical Practice & Guidance for in vivo bioequivalence studies valid through to the 1st of January 2021.
This assessment is one of the first steps in the prequalification process when submitting a finished pharmaceutical product (FPP) as an Expression of Interest for Product Evaluation (EOI). EOIs are issued by WHO, by therapeutic area, following consultation with WHO disease programmes and/or clinical specialists. FPPs invited for evaluation have been identified by WHO clinical experts as vital to effective treatment and expansion of treatment programmes worldwide.
Headquartered in Toronto, Canada, the Full-Service Contract Research Organization (CRO) is specialising in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide. it comprehensive services include Bioanalysis at GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.
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