We offer analysis of biological samples from all types of studies. We work in compliance with Good Laboratory Practice (GLP) and relevant ICH, EMA and FDA guidelines are followed. We have experience of working with non-clinical dose formulation analysis (NCDFA) and we also perform method development and validation of bioanalytical methods.
Our bioanalytical services include:
- Method development for partners without their own bioanalysis method, or method transfer for existing methods, followed by validation according to FDA and EMA Guidelines
- The highest quality bioanalytical services for qualitative and quantitative drug and metabolite analysis in a variety of matrices
- Bioanalysis of biomarkers
- Support for preclinical studies meeting full GLP requirements and small sample volumes, as well as for clinical studies with a large number of samples such as bio-equivalency and bioavailability studies
- Bioanalytical support for clinical dose escalation studies (SAD and MAD) with short turnaround times and small sample volumes
- Dosing solution analysis for GLP studies
- Synthesis of internal standards, either stable isotope-labelled or suitable analogue
- Automated 96-well sample processing and analysis
- Cutting edge technology with automated and analytical instrumentation (high sensitivity and specificity with LC-MS/MS).
Explorative bioanalytical services are also offered. This may include analysis of tissue and cell cultures, protein binding and small series with many analytes.
For an integrated phase I solution our Recipharm Pathway to Clinic® offering takes new molecules seamlessly and speedily from formulation development to first in human (FIH) studies, including bioanalysis. Find out more.