Bioanalytical laboratory Clinfarm LLC
GLP-certified laboratory specializing in pharmacokinetic studies of medicines and drugs, including studies of bioavailability and bioequivalence of generics
Our servicesThe laboratory adheres to the recommendations of the WHO and the regulatory authorities of the State Expert Centre of the Ministry of Health of Ukraine, EMA, and FDA.
About Us
Bioanalytical Laboratory Clinfarm LLC is a GLP-certified laboratory specializing in pharmacokinetic studies of medicines and drugs, including studies of bioavailability and bioequivalence of generics. The laboratory adheres to the recommendations of the WHO and the regulatory authorities of the State Expert Centre of the Ministry of Health of Ukraine, EMA, and FDA.
Since its foundation in 2006, the laboratory has completed more than 90 projects to assess the pharmacokinetic properties of original medicinal products and bioequivalence of generics registered in Ukraine, Asia and the European Union.
Clinfarm LLC works in cooperation with domestic and foreign pharmaceuticals manufacturers and CROs.
Clinfarm LLC is also certified by the State Administration on Medicines and Drugs Control of Ukraine for the right to conduct quality and safety control of medicinal products in accordance with the scope of certification for independent laboratory control of medicinal products: 2.2.43- Mass-spectrometry
Equipment
Clinfarm LLC is equipped with three UPLC-MS/MS spectrometers (ACQUITY UPLC - Quattro Micro API (Waters, USA), ACQUITY UPLC/H-Class - XEVO TQD (Waters, USA) and Agilent 1260 Infinity II Ultivo LC/TQ (Agilent Technologies, USA), equipment for solid-phase and liquid-liquid extraction, a system for obtaining ultrapure water, low-temperature freezers, etc., which allows to perform a full range of bioanalytical work on the study of pharmacokinetics and bioequivalence of medicinal products.
Personnel and quality system
Clinfarm LLC has highly qualified and experienced team of specialists in the field of bioanalytical chemistry, chromatography, mass spectrometry and pharmaceutical analysis. The laboratory employs 2 PhDs.
The bioanalytical laboratory of Clinfarm LLC has an effective quality assurance system in accordance with GLP requirement to perform
in accordance with standard operating procedures (SOPs). This ensures complete traceability of primary data and research results, reliable archival storage of primary documentation, plans and reports in electronic and printed versions.
Our principles and advantages
20 years of experience in pharmacokinetic and bioequivalence studies
high professionalism of the entire team of employees
ensuring the quality of research: objectivity, reliability and traceability of results
honesty and openness to audits
absence of conflict of interest
compliance with confidentiality
Our services
