The procedures regarding medicines are regulated by several national and European norms. In this sector, Di Renzo Regulatory Affairs offers the following services:

• Consultancy activity on the national and international reference regulations
• Preliminary evaluation of the documentation before submitting to the Ministry of Health
• Cooperation for marketing authorization applications for national, mutual recognition and decentralised procedures, with both Italy and other European countries as RMS
• Preparation of the documentation for variations and renewals
• Integration of the dossier with the additional documentation requested by the Ministry of Health
• Assistance throughout the entire bureaucratic process until the issue of the relative authorizations for the marketing authorisation, manufacturing sites of raw materials and finished products authorizations
• Preparation of the products information documentation (SPC, labels and patient information leaflets) in accordance with the current laws
• Applications for various certificates (Free Sales Certificates, GMP, Certificate for Importation of dangerous substances, certificates for importation of samples for clinical studies or other uses)
• Relations with foreign consulates in Rome for the issue of visas
• Suitability to transmit data to Eudravigilance
• Due diligence
• Assist companies in meetings with assessors of the Ministry of Health and other relevant organisations from this sector

Furthermore, Di Renzo Regulatory Affairs has singled out some operative units in its own structure in order to manage some activities that are becoming increasingly more outsourced.