Quality System

Our quality system, resources, and facilities are managed to meet the regulatory authority requirements and international standard for GCP, GLP, and BA/BE study to ensure the acceptance of our study report by Drug Regulatory Authority.

Our Quality Assurance ensures that every study is performed in compliance with the general regulatory requirements and international standards that cover every aspect of the study, such as: Guideline Good Clinical Practice (GCP), Guidance Good Laboratory Practice (GLP), ISO/IEC 17025;2017, “Pedoman Uji Bioekivalensi” published in 2015 by National Agency of Drug and Food Control (BPOM RI), "Tata Laksana Uji Bioekivalensi" published in 2022 by Regulatory of National Agency of Drug and Food Control No 11 (BPOM RI), Guideline EMEA, FDA, and ASEAN.

Our functioning Quality Assurance personnel rigorously inspect and monitor every aspect of those respective standards and conducted based on the latest version of each guideline.