BA/BE sample analysis
Full-scale bioanalysis of BA/BE samples for PK studies in healthy volunteers and patients.
A small-molecule and biologics lab.
A state-of-the-art 6,000 sq ft bioanalytical laboratory, from early discovery to post-marketing studies.
Accurate, reliable, streamlined
We specialize in comprehensive PK/TK, pharmacology, bioequivalence and bioavailability studies, ADA, NAb and biomarker assays, and clinical sample analysis, from early discovery and preclinical bioanalysis to clinical and post-marketing studies. We work with some of the world's largest pharmaceutical and biopharmaceutical companies.
From method development through clinical sample analysis, we are dedicated to accurate, reliable and streamlined bioanalytical services for the most challenging programs, so you can make confident research decisions. Our team has a proven track record of developing sensitive, reliable methods for NCEs, hormones and vitamins, and of submitting to international regulatory bodies.
Our expertise spans
- Chromatography
- Mass spectrometry
- Immunochemistry
- Cell-based assays
- Flow cytometry
- Molecular biology
Services
What we do in the lab
Method development & validation
We develop, transfer, optimize and validate methods for quantitative and qualitative drug and metabolite measurements.
Compound screening
Compound identification and screening to predict drug uptake and elimination, using non-GLP research-grade assays.
Discovery bioanalysis
Early-stage bioanalytical support to move promising candidates forward with confidence.
Quality built into every result.
Our SOPs ensure compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and current bioanalytical guidance from the relevant regulatory bodies. All systems run 21 CFR Part 11 compliant software with full audit trails enabled.
BioRadius also has strategic and technical alliances with researchers and scientists from renowned research institutes, universities and companies, for subject-matter consultation, training and project execution on an as-needed basis.
Have a product in the pipeline?
Let's bring it to the market together. Tell us about your product and timelines, and we'll come back with a plan and a quote.