Pharmaceutical Regulatory Consultants
Di Renzo Regulatory Affairs cooperates with an International net of companies in the pharmaceutical regulatory consulting in all Member States of the European Community and in the main extra-EU countries.
The mission of Di Renzo Regulatory Affairs is to offer regulatory consultancy to pharmaceutical companies intending to obtain marketing authorizations for medicines for human use, veterinary medicines, food supplements and medical devices.
Our Rome office, located near the historical city centre, allows us to reach the Ministry of Health, AIFA (Italian Medicines Agency) and the Health High Institute easily and quickly. Our regulatory company has an office also in Milan, in order to facilitate pharmaceutical companies from the North Italy and North Europe.
At the end of the ’80s, the European Community started a harmonization of the regulations of pharmaceutical products in all Member States. Since then, pharmaceutical industry has undergone deep changes, with the introduction of complex, ever changing authorization procedures.
This radical transformation required a deep knowledge of the regulations of this field, highlighting the need to keep up with continual technical and normative updates. Therefore, the availability of experts able to deal with technical and scientific issues but also mastering National and European regulations has become essential. On the base of such needs, in 1985 Sante Di Renzo founded the company Di Renzo Regulatory Affairs.
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At the turn of the '50s and '60s between 10,000 and 20,000 children were born with severe deformities due to the assumption by pregnant women of a thalidomide-based drug. This is the most prominent case of a side effect of medication. Thalidomide was tested in a hurried and hasty manner, and the case caused such a backlash that the already existing FDA received an award from President Kennedy for blocking the sale of the drug and requested that other studies be carried out.| Partner: |  |
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