Our Certifications
Successfully inspected by the U.S. Food and Drug Administration, confirming full compliance with FDA standards for bioanalytical and clinical research operations.
Completed the FDA's Remote Regulatory Assessment (RRA), a remote evaluation verifying continued compliance with applicable regulatory requirements.
Inspected by the Belgian health authority (AFMPS), demonstrating compliance with European Union Good Manufacturing and Clinical Practice requirements.
Inspected by the Spanish health authority (AEMPS), verifying adherence to EU regulatory standards for clinical trial conduct and data integrity.
Accredited by ANVISA, Brazil's health regulatory agency, recognizing PRU's compliance with international standards for pharmaceutical research.
Accredited by Malaysia's National Pharmaceutical Regulatory Agency (NPRA), supporting the acceptance of PRU study data for Malaysian regulatory submissions.
Accredited by the Turkish Ministry of Health, enabling PRU-generated study data to support product registration in Turkey.
Holds Gulf Cooperation Council accreditation, supporting the acceptance of PRU's research across GCC member states for regional product registration.
Accredited by the Jordan Food and Drug Administration, authorizing PRU to conduct pharmaceutical research and clinical trials within the Hashemite Kingdom of Jordan.
Recognized by Kazakhstan's National Center for Expertise of Medicines (NDDA), supporting the use of PRU study data for regulatory submissions in Kazakhstan.