TORONTO--(BUSINESS WIRE)--BioPharma Services, Inc. (BioPharma) is proud to announce the successful completion of a GCP/GLP/BE assessment by the World Health Organization (WHO). The assessment included the review of two clinical studies performed at BioPharma’s Toronto, Canada site and were found to be in compliance with WHO Good Clinical Practice & Guidance for in vivo bioequivalence studies. With this successful assessment, BioPharma received a status of Compliance 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.
Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs at BioPharma said “We are very proud to be able to support pharmaceutical companies working to make a difference in treating diseases such as HIV/AIDS, TB and malaria which affect millions and are pleased to have the high standards of our facilities validated by WHO for the next three years”.
Renzo DiCarlo, CEO further remarked “Today, I’m exceptionally proud of our team and delighted to now be one of the few clinical research companies worldwide to have received certification by WHO”.
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 USA and in Canada with a total bed capacity of 300 with access to healthy volunteers, special populations and patients. Headquartered in Toronto, Canada, BioPharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.