Biotrial Bioanalytical Services (BBS), a GLP-certified contract laboratory, offers a range of bioanalytical services and uses state-of-the-art technology such as LC/MS for the accurate quantification of drugs in biological matrices. We support the drug development programs of generic drug companies, pharma and biotech companies by carrying out bioavailability/bioequivalence studies as well as developing and validating methods and performing high-throughput analysis of samples obtained from pre-clinical studies up to and including clinical trials for innovator compounds.
Among one of the features that distinguishes BBS and for which we are recognized is the ability to develop some of the most challenging assays. A highly trained team of R&D scientists uses the latest techniques and routinely resorts to custom synthesis of stable-labeled reference compounds and metabolites to ensure that the methods are sensitive, robust and highly selective.
Our validation specialists, working closely with R&D, rigorously and meticulously test the method in accordance with the most recent regulatory agencies’ (FDA, EMA, and Health Canada) requirements. Experienced and well-trained members of our production team provide among the industry’s fastest turnaround time delivering all studies including the much sought after, first-to-file studies, on time and without compromise to quality.
Our attention to detail and personalized service attests to our commitment to establishing long-term relationships with our sponsors.