BRI Biopharmaceutical Research Inc.

Overview

BRI Biopharmaceutical Research Inc. is a specialized analytical, bioanalytical and DM/PK contract research organization (CRO) servicing pharmaceutical and biotechnology companies in discovery, preclinical and clinical programs supporting IND and NDA-enabling studies.

The bioanalytical LC/MS/MS group was operating since 1999 founded by Dr. David Kwok. Over the years BRI performed hundreds of quantitative assays on small molecule drugs, metabolites and chemical biomarkers supporting Phase I to IV Clinical PK samples and DM/PK preclinical samples. Bioanalytical assay experience includes immunochemical ELISA and cell-based assays of small molecule chemical biomarkers and large molecules.

BRI has also performed hundreds of CMC studies highly experienced in analytical chemistry and USP monograph assays including HPLC, GC/Headspace assay and GC/MS assay of drug substances, impurities, degradation products and clinical products including parenteral liquids, capsules, tablets, and semi-solid topical formulations.

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

Qualifications, Certifications, Accreditations & Licenses

BRI Biopharmaceutical Research Inc. is certified under the Canadian Council of Animal Care (CCAC) and Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).