WHAT BUSINESS ARE WE IN

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

Guidelines

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