At the end of the '80, the European Community initiated a harmonization procedure for the regulations of pharmaceuticals in all Member States. Since then the pharmaceutical industry has undergone significant changes, with the introduction of complex authorization procedures, which are in constant development.

This radical change has necessitated an in-depth knowledge of the norms in this field, highlighting the need to be abreast of all the continuous technical and normative updates. The availability of experts able to deal with technical and scientific topics along with knowledge of the national and European provisions has thus become essential.

In 1985, Sante Di Renzo established the firm Di Renzo Regulatory Affairs avails itself of a vast and professional working staff, as well as several expert consultants who have a longstanding experience in the field of all aspects of regulatory affairs.