Di Renzo Regulatory Affairs is a leading regulatory consulting firm with over 40 years of experience.
The services offered include medicinal products for human and veterinary use, medical devices, dietary supplements, cosmetics, biocides, medical and surgical devices, and related products.
It also has units dedicated to pharmacovigilance, medical device vigilance, cosmetovigilance, scientific information, quality management systems, and many other aspects of regulatory management.
With a strong international organization, the firm collaborates with numerous regulatory consultants in each European country and major non-European countries.
With the considerable expertise gained over the years and an organization comprised of numerous experts with degrees and medical and scientific training, Di Renzo Regulatory Affairs is able to offer appropriate and timely guidance, regulatory strategies, and services in each of the aforementioned areas of interest.
Medicines for Human Use
Our services for human medicines
Veterinary Medicines
Our services for human and veterinary medicines
Medical Devices
Our consultancy for manufacturers and distributors
PMC and Biocides
Services for PMC and Biocide manufacturing companies
Cosmetics
Our experts at the service of cosmetic companies
Food Supplements
Consulting for manufacturing and importing companies
Di Renzo Regulatory Affairs began operations in 1985 and has developed its organization to international standards over time. The company’s numerous experts hold degrees in scientific disciplines: chemistry, medicine, pharmacy, chemistry and pharmaceutical technology, engineering, biology, biotechnology, statistics, and more.
In 2019, Di Renzo Regulatory Affairs moved to a new operational headquarters, still located in Rome, but larger and more appropriate for its numerous and complex activities. The headquarters is close to the Ministry of Health, the AIFA (Italian Medicines Agency), and the National Institute of Health.
Di Renzo Regulatory Affairs also has two other offices, one in Milan and the other in London.
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The importance of GMP audits for Human and Vet drug manufacturing
The verification of the compliance with the regulations in force, in particular with the Good Manufacturing Practice (GMP), Eudralex vol.4, via dedicated audits allows the systematic evaluation of manufacturing processes,
Managing shortages between regulatory obligations and patients’ protection
The market shortage of medicinal products is now a global issue, that is continuously discussed by regulatory authorities and trade associations. It is a particularly sensitive topic, involving more stakeholders
Self-medication drugs, new AIFA guidelines for no prescription drugs and OTCs
A new decree of the Italian Medicine Agency is in the process of being published in the Official Journal, laying down the “Adoption of the new guidelines on the definition