Carmine Spina

Di Renzo Regulatory Affairs

Di Renzo Regulatory Affairs, established in 1985, avails itself of a vast and professional working staff (about sixty people), as well as several expert consultants who have a longstanding experience in the field of all aspects of regulatory affairs. Di Renzo Regulatory Affairs cooperates with two international networks (Eudracon and Tarius) of regulatory agencies and consultant offices throughout the European Community. The main office is situated strategically in the centre of Rome (Viale Manzoni 59) not far from the Ministry of Health, the Italian Pharmaceutical Agency (AIFA) and the Istituto Superiore di Sanità. The other Italian office is located in Milan, Piazza Luigi di Savoia, 24. We offer our services in the following fields: Medicinal products for human and veterinary use Local and international pharmacovigilance requirements Advice and assistance with clinical trial applications Scientific Information, Due diligence, CTD, eCTD, Traceability,Readability test, Pricing dossier, preparation SOPs, etc. Preparation of the necessary documentation regarding certificates and licences (e.g. Free Sale Certificates, GMP certificates, and narcotics licences) Preparation of the Risk Management Plan (RMP) Preparation, maintenance and update of the Pharmacovigilance System Master File (PSMF) Preparation, revision and update of Safety Data Exchange Agreements (SDEA) Medical devices and devicevigilance Biocides Cosmetics and cosmetovigilance Food supplements, dietetic products and foodvigilance Translations. We can speak Italian, English, French, German, Spanish, Greek, Portuguese, Chinese. Organisation and printing of promotional material (advertising material, SPCs, PILs, labels etc) through our in-house IT and graphic department Assist clients with contacts in other countries through our international networks of consultancies, with whom we co-operate on a regular basis.