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.