About

Bioanalytical laboratory CSU "Analytical Spectrometry" 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.

We offer our clients customized solutions and work with complex implementations according to custom requirements:

Analytical methods development and validation in accordance with local and international requirements (FDA, EMA)
High-throughput analysis for clinical and pre-clinical studies
Statistical analysis of data using SAS and/or WinNonLin
Biowaiver studies
Safety report and final report development for clinical and pre-clinical studies in accordance to local and international requirements
Long-term storage at ≤-18 °С и ≤-65°С

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.

The quality of conducted researches is provided by highly qualified personnel, reliable equipment, quality assurance system, standard operating procedures regulating staff actions.

Our Quality Assurance system includes scheduled internal audits aimed at deviations finding and corrective actions implementing. The studies are controlled at all stages: during the method development and validation; when biological samples are being analyzed; at the final stage of research (during data calculation and report development).

Huge background of our company includes methods development for endogenous substances, drugs with ultra low limits of quantitation, unstable molecules, and multi-compound compositions which would help to find an individual solution for every complex object.

Our experiences include more than 120 bioanalytical studies and analyzing more than 65 000 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.