PharSafer Processing of ICSRs and SUSARs

PharSafer has been reporting electronically for clients since January 2008, processing both ICSRs and SUSARs in Europe (EMEA) as well as with the FDA in the USA. Over this time we have tested with all of the Regulatory Agencies capable of reporting electronically using EVWeb technology as well as Gateway requirements and have extensive knowledge of setting up clients for electronic reporting using cost effective models and documented procedures for the set up and processing of such events.

Additionally, PharSafer has been working with clients using the Eudravigilance Medicinal Product Dictionary Database (EVMPD) for the registration of Company products using the Eudravigilance guidelines, helping Companies remain compliant.