BioAnalytical Research
Bio-analytical department of BioRadius is a small-molecule and biologics –focused analytical laboratory operating on a state-of-the art 6000 sq.ft area.
Bio-analytical department of BioRadius is a small-molecule and biologics –focused analytical laboratory operating on a state-of-the art 6000 sq.ft area. We specialize in comprehensive PK/TK, pharmacology, bioequivalence and bioavailability studies, ADA, Nab, Biomarker assays and clinical sample analysis from early discovery and preclinical bioanalysis to clinical and post marketing studies. We work with various world’s largest pharmaceutical and biopharmaceutical companies and our expertise spans:
- Chromatography
- Mass spectrophotometry
- Immunochemistry
- Cell-based Assays
- Flow cytometry
- Molecular biology
From method development through clinical sample analysis, we are dedicated to performing accurate, reliable, and streamlined bio analytical services for the most challenging programs to help you make confident research decisions. Our bio analytical team members have proven successful track record of developing sensitive and reliable methods for NCEs, hormones, Vitamins and have submitted to various International regulatory bodies.
Our services include:
- Full scale bio analysis of BA/ BE samples for PK studies in healthy volunteers and patients
- Develop, transfer, optimize and validate methods to clients for quantitative and qualitative drug and metabolite concentration measurements
- Compound identification and screening to predict drug uptake and elimination though non-GLP research grade assay approach.
- Discovery bioanalysis
Our SOPs confirm compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (cGLP), and current regulatory bioanalytical guidance documents issued by the relevant regulatory bodies. 21 CFR Part 11 compliant software with full length audit trial enabled systems. BioRadius boasts of strategic and technical alliance with various researchers and scientists from renowned research institutes, universities and companies to facilitate subject matter consultation, training and execution of projects, on an “as-and-when” basis.
