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BRI Biopharmaceutical Research Inc.

101 - 8898 Heather Street

Vancouver, BC V6P 3S8 CA


Standards / Methodologies:

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

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

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

DISCLAIMER: This Laboratory Profile was provided by the company above.