Skip to content

REGULATORY AFFAIRS CONSULTANCY IN COMPLIANCE WITH LEGISLATION

The registration processes for medicines, medical devices, dietary supplements and cosmetics are rigorously regulated and need the understanding of all the legislative aspects, for a correct application of regulations.

Il nostro obiettivo è di indirizzare e affiancare il cliente, al fine di operare in compliance agli aspetti normativi di settore.

Thanks to our team of experts in regulatory affairs regarding Italian and European regulations, we offer our consultancy to realize the documentation necessary to obtain

Marketing authorization (MA, AIC in Italy) for medicines,

Registration of cosmetics, medical devices, dietary supplements, medical-surgical aids and biocidal products, as well as their relative submission. esperti in ambito regolatorio delle normative nazionali ed europee, svolgiamo attività di consulenza per la realizzazione della documentazione necessaria all’ottenimento dell’Autorizzazione all’Immissione in Commercio (AIC) per i medicinali, e della documentazione ai fini registrativi per cosmetici, dispositivi medici, integratori alimentari, presidi e biocidi, e relativa sottomissione.

 

Moreover, we are the connection between companies and the Italian Medicines Agency (AIFA), Ministry of Health and Notified Bodies.

Our consultancy includes also the preparation of:

 

  • Expert reports, epidemiological studies, pharmacoeconomic studies, and preparation of scientific articles for publication in indexed journals.