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The bioanalytical laboratory of Unifarm provides three standard tiers of bioanalytical qualification methods, from the preliminary phase/method development and the validation method, up to full regulatory-enabling GLP bioanalysis.

All methods are validated according to EMA-FDA guidance. Our laboratory has a wide assortment of analysis instruments.


Unifarm is self-certified as Contract Research Organization (CRO) at Italian Medicines Agency (AIFA), in compliance with the Italian Ministerial Degree DM 15/11/2011.

Unifarm is certified by the Provincial Health Service of Catania according to Italian Ministerial Decree DM 19/03/1998 and it is included in the Registry of private laboratories of the National Monitoring Centre for Clinical Trials (OsSC) with Medicines.

Unifarm is self-certified as bioanalytical laboratory at Italian Medicines Agency (AIFA), in compliance with the requirements of the Determination n. 809/2015 19/06/2015 regarding phase I clinical trials.

Unifarm is certified as a Good Laboratory Practice (GLP) laboratory by the Italian Ministry of Health and according to the Legislative Decree D.L. 02/03/2007, n. 50 – Directive 2004/9/EC for pharmacokinetics and metabolism studies; analytical part only.

Bioanalytical Services

  • Analysis of drugs and metabolites in biological fluids

  • High-capacity, high-throughput GLP/GCP bioanalysis for small molecules

  • Non-GLP discovery bioanalysis

  • Drug-drug interaction (DDI), Absorption, Distribution, Metabolism, and Excretion (ADME), Pharmacokinetics (PK), Toxicology, and Bioequivalence/Bioavailability studies

  • Large analytical method library

  • Fast sample analysis turnaround

  • Inspections and Quality Assurance

  • Exemplary regulatory compliance


  • Liquid chromatography–mass spectrometry (LC-MS/MS)

  • High Performance Liquid Chromatography (HPLC) with Diode-Array Detection (DAD) and Electrochemical Detection (EC)
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