Bioanalytical laboratory CSU "AS" offers a wide range of services to the pharmaceutical and biotechnology industries, specializing in bioavailability (BA), bioequivalence (BE) and pharmacokinetics (PK).
We support companies in their drug development programs by carrying out analyses generated throughout the program, beginning with pre-clinical studies and proceeding with evaluation of the drug in human clinical trials according to GLP requirements. Support to the generic drug industry is provided by analyzing physiological fluid samples obtained from clinical studies in humans to determine whether the new formulations are bioequivalent to the marketed product.
According to your project we can develop and validate specific bioanalytical method and carry out complex studies:
Development and validation of analytical methods;
High-throughput analysis for clinical and pre-clinical studies;
Long-term storage at-20oC and-70oC.
Our specialists are dedicated to providing a complete service for fulfilling your own new-product goals. Our research projects are conducted in an efficient and strictly confidential manner. Through our commitment to excellence, our experienced scientists employ the latest development in pharmacology, bioanalytical chemistry and techniques and modern analytical equipment. The latest analytical technologies and process of sample preparation are applied for the determination of trace drug levels in complex matrices.
We carry out development of high-performance analytical methods and fully validation in accordance with the current guideline of FDA and EMA. Quality management system is certified ISO 9001:2008 by IQNet, ACCREDIA.
Our experiences include more than 90 bioanalytical studies and analyzing more than 30 000 samples per year. Our scientific team will find a customized solution for your task. If you need a quotation please fill in the form of BIOANALYTICAL SERVICES REQUEST.
We aspire to build a long-term relationships with our partners and colleagues. If you have any questions don`t hesitate to contact us.
Gzhatskaya st.27, office 240