CSU "Analytical Spectrometry" provides a range of services to the pharmaceutical and biotechnology industries. We focus on quantitative determination of pharmaceuticals and biomarkers in physiological fluids and tissues (BE, PK, PD, BA, and TDM) in accordance with the most recent regulatory agencies requirements (FDA, EMA).
Our services are:
- Method development and validation
- Sample analysis for clinical and non-clinical studies
- Pharmakinetic and statistical data evaluation
- Reporting of study results
- Long term sample storage -20oC and -70oC
The method validation includes following parameters:
- Accuracy and precision;
- Recovery of analyte and IS;
- Long-term stability;
- Autosampler stability;
- Short-term stability;
- Freeze and thaw stability;
- Matrix effect;
- Carryover effect;
- Dilution integrity;
We ensure that our clients receive professional and reliable bioanalytical support with high quality levels and delivery schedules. We use state-of-the-art equipment and the latest techniques to develop highly exacting analytical methods that are validated in accordance with FDA and EMA standarts.
If you have any questions. don`t hesitate to contact us.
Gzhatskaya st.27, office 240