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 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
Ms. Anna Taylor, Executive Vice President, Business Development, BioPharma Services, Inc.