Following the assessment, Biopharma Services, a Phase I/IIa and bioequivalence contract research organization (CRO), received a status of compliance from the World Health Organization (WHO) valid through January 1, 2021.
This status was received after the assessment by WHO demonstrated that Biopharma’s site met the guidelines of current good laboratory practices (cGLP), good clinical practice (GCP), as well as the European Medicines Agency regulations (EMA), Medicines and Healthcare Regulatory Association (MHR) guidelines, and International Standardization Organization (ISO) processes.
The assessment included the review of two clinical studies found to be in compliance with regulatory guidelines required by the World Health Organization’s (WHOs) for in vivo bioequvialance studies. The studies were conducted at the company’s Toronto, Canada site.
Renzo DiCarlo, CEO of Biopharma Services told us that the status of compliance “will also open the door for us [the company] to work with many WHO foundations.”
According to Biopharma, the assessment is one of first steps in the prequalification process when submitting a finished pharmaceutical product as an expression of interest for product evaluation (EOI). EOIs are issued by WHO following the consultation of the organization’s disease programs and clinical specialists.
Previous to this assessment, the Canada-based company completed three FDA inspections in 2017 with zero observations. The company previously stated that it received no Form 483’s or observations after its FDA inspection in 2015 either.
The company has an additional site in Columbia, Missouri as well as affiliate relationships with Brazil, China, and the eastern European region.