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.
CERTIFICATION & ACCREDITATION
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.
- 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)