Unifarm University Consortium (Consorzio Universitario Unifarm, UNIFARM) was founded in Catania in 2002 by Filippo Drago, Professor of Pharmacology at the School of Medicine, University of Catania, in cooperation with the University of Catania and twelve major multinational pharmaceutical companies. In the same year the Research Centre in Clinical Pharmacology the first in Central...read more

UNIFARM is a CRO registered at  the Agenzia Italiana del Farmaco (Italian Authority for Drugs, AIFA), compliant with the requirements of the DM (Ministerial Decree) dated March 31, 2008 on clinical trials and therefore able to provide services such as: clinical study design; project management; preparation of study protocols and other regulatory documents; approval procedures...read more

UNIFARM has implemented a Quality System in line with national and international regulations to ensure high level of service and client satisfaction. Indeed, this is one of the main objectives of UNIFARM and is constantly pursued through the involvement of all the personnel in a quality process based on the assumption of individual responsibility, as well as through the implementation of systems and procedures...read more

Regulatory affairs

Regulatory affairs services:

- revision and assesment of technical and scientific data; 
- bibliographic research;
- preparation and management of the Site Master File;
- consulting on interpretation of regulatory requirements and guidance;
- strategic regulatory planning;
- preparation and assembly of submissions for the ethical examination and obtaining approval for clinical trial from the ethic committees.

 

Unifarm è un Centro di Saggio (CdS) certificato dal Ministero della Salute,
in Buona Pratica di Laboratorio (BPL)