equilab quality

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 in many countries including regulated market, hence Equilab can support customer needs to export their product in many countries.

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.

According to the national regulations, the whole aspect and step in BA/BE study have been regulated and well explained in the complete guidance ”Pedoman Uji Bioekivalensi” published in 2004 by National Agency of Drug and Food Control Approval (BPOM). We also adopt guideline from 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.