Our Vision

To become an independent World Class Contract Research Organization, emphasizing Bioequivalence studies and recognized by local and international customers.

Our Mission

To conduct reliable, rapid, and high-quality research services on bioequivalence studies with conformance to current national and/or international standards and guidelines.

Our Values

  • Independency
  • Professionalism
  • Confidentiality, and Integrity
  • Efficient
  • Expertise and Commitment to the quality and ethical conduct
  • Care, responsive, and reliable

The Rules


BA/BE Study Guideline

  • Committee for Medicinal Products for Human Use (CHMP), EMEA (The European Agency for The Evaluation of Medicinal Products): Guideline on the Investigation of Bioequivalence, Jan 2010
  • EMEA (The European Medicines Agency), Procedure for Conducting GCP Inspections Requested by The EMEA: Bioanalytical Part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials (Annex VII), March 2008
  • Center for Drug Evaluation and Research (CDER), FDA: Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations, March 2003
  • WHO Technical Report Series, No. 937, 2006., Annex 9: Additional guidance for organizations performing in vivo bioequivalence studies
  • ASEAN Guidelines: “The Conduct of Bioavailability and Bioequivalence Studies”, 2015.
  • BPOM Indonesia: “Pedoman Uji Bioekivalensi”, 2015.
  • BPOM Indonesia, Peraturan BPOM No 11 Tahun 2022 Tentang "Tata Laksana Uji Bioekivalensi"
  • BPOM Indonesia, Keputusan Kepala BPOM RI No 65 Tahun 2022 Tentang "Daftar Obat Generik Tertentu Wajib Uji Bioekivalensi"

GCP Guideline for Clinical Aspect

  • GCP ICH-E6, 2016
  • EMEA (The European Medicines Agency), Procedure for Conducting GCP Inspections Requested by The EMEA: Sponsor Site and/or CRO (Annex IV), Sept 2007
  • EMEA guidance related to the implementation of GCP_INS/GCP 1-4, and corrigendum
  • WHO Technical Report Series, No. 850, 1995, Annex 3: Guidelines for good clinical practice (GCP) for trials on pharmaceutical products
  • BPOM:“Indonesian Guideline for Good Clinical Practice”, 2016

GLP Guideline for Bioanalytical Aspect

  • EMA : “Guideline on Bioanalytical Method Validation”, July 2011
  • ISO 17025:2017