Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research
Services  Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research
 Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research
 Bioanalytical & Drug Metabolism Research  Bioanalytical & Drug Metabolism Research

Regulatory Compliance

GLP Compliance

At BRI, the Quality Assurance Unit is an integral part of our operation in every study. Study Directors, scientists and the QAU all shared a common value in providing the highest level of uncomprised data quality in every study. From sample shipment inventory to automated Therm-Watson? LIMS data reduction and reporting, we have successfully performed and delivered hundreds of bioanalytical and DM/PK studies under GLP.

BRI follows the following Good Laboratory Practice Regulations/ Standards/ Guidelines, including:

  • United States Food and Drug Administration, Title 21 Code of Federal Regulations Part 58, Current
  • Organization for Economic Cooperation and Development,
    The OECD Principles of Good Laboratory Practice, Series on Principles of Good Laboratory Practice and Compliance Monitoring, Monograph No.1 to 14, current
  • Japanese Ministry of Health and Welfare, Ordinance No. 21,
    April 1, 1997

GLP Practices and Standards

BRI Biopharmaceutical Research Inc. is licensed under the following regulated activities:

  • GMP / GLP Establishment License by Health Canada for supporting manufacturing QC testing of API and drug products
  • CNSC Nuclear Substance License by the Canadian Nuclear Safety Commission for the use of 14C and 3H isotopes
  • CCAC accredited by the Canadian Council on Animal Care for use of laboratory animals
  • Canadian Council on Animal Care

  • AAALAC accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International for use of laboratory animals
  • aaalac

  • Controlled-drug licenses for a variety of controlled and scheduled drug substances
  • CFIA Animal Pathogen Import Permit
  • Health Canada Human Pathogen Importation Permit

 Bioanalytical & Drug Metabolism Research


 Bioanalytical & Drug Metabolism Research