History: Open Joint-Stock Company "Clinfarm" is a non-state-owned organisation (legal body) founded in May, 2006 which is engaged in the organisation and carrying out pharmacokinetic studies and bioequivalence research of medicinal products.

Goals of the bioanalytical laboratory "Clinfarm": carrying out objective pharmacokinetic research according to the requirements of the European Union (EU) and the World Health Organization (WHO) toward full satisfaction of its customers: both leading pharmaceutical manufacturers and consumers - public health service systems - in obtaining objective and authentic data about the efficiency, safety and quality of medicines.

Basic principles of laboratory's operation: high professionalism, maintenance of research quality: objective nature, reliability and transparency of the results, honesty and openness for any audits, absence of conflict of interests, strict confidentiality.

Predispositions for the set objectives to be reached: unconditional conformity to the developed and adopted by ОЕСD principles of good laboratory practice (GLP), stated in EU legislation, observance of WHO recommendations and FDA guidelines comprising, but not limited to the following:

• Qualified personnel is available (all our employees possess profiled higher university education - chemical, biological, work experience in their speciality of not less than 5 years). ;

• Functioning of the efficient system of quality maintenance according to GLP requirements. Our Deputy Director on quality has the necessary field experience and corresponding qualification as regards the issues of creating and functioning of the quality systems in the area of manufacturing and control of medicinal products;

• Laboratory premises are designed, planned and constructed according to GLP principles. The necessary indoor temperature and humidity are maintained by the system of central air-conditioning;

• The laboratory is equipped with advanced facilities, including: systems for production of purified and super-pure water, low-temperature deep-freezers, scales, spectrophotometer, refractometer, pH metre, liquid chromatograph with mass spectrometer detector, systems for sample preparation, etc. Laboratory uses the materials and reactants made only by well-known manufacturers;

• Research is carried out in strict conformity to the approved plans, in particular, concerning full preliminary and subsequent validation of employed techniques;

• All actions are carried out according to standard operational procedures (SOP) which are developed, approved and circulated in the laboratory according to the functioning quality maintenance system;

• Complete continuity of the results of conducted research is ensured, in particular based on their automatic electronic recording from each unit of the analytical equipment to the database;

• Report formation is completely automated due to the functioning of local computer network supported by the server;

• Maintenance of archival storage of primary documentation, schedules and reports in electronic and printed formats for as long as 20 years, storage of samples during the time established by standard requirements and contractual obligations.

The laboratory calls for cooperation of the manufacturers of medicinal products, contract research organisations, other sponsors for carrying out pharmacokinetic research/study of bioequivalence of medicines according to the standard international practices, requirements by regulators of Ukraine, CIS, European Union, USA and other countries.

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