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.

Medical Devices

Pharmaceutical

Di Renzo Regulatory Affairs

Sante di Renzo

Laura Borghesi

Francesca Savina

Regulatory Affairs

Monica Chiari

The Regulatory and Pharmacovigilance Team at Di Renzo Regulatory Affairs ensures compliance with local and international regulatory requirements for medicinal products, medical devices, biocides, and cosmetics. They oversee the preparation and maintenance of necessary documentation, manage pharmacovigilance systems and safety data, and provide expert advice on clinical trials and risk management plans. Additionally, this team liaises with international networks to support global regulatory activities and ensures the highest standards of safety and efficacy for products entering the market.

Regulatory and Pharmacovigilance Team

About

Team members