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Regulatory Support


The marketing and distribution of pharmaceuticals in Italy is strategically all services relating to regulatory activities (Regulatory Affairs).

Petrone Group, thanks to its experience, is able to provide full support and management of all the paperwork for obtaining and maintaining authorizations.

Since they support the central Italian national procedures with the compilation of dossiers that need to be updated, the regulatory office is in a position to keep all the national and European procedures, including relationships with the relevant health authorities (AIFA, EMEA, Ministry of Health), as well as pharmacovigilance and post-marketing surveillance.

Regulatory services are of course also available for all export procedures useful to Italian producers who wish to expand their market in Europe and worldwide.