SafetyDrugs database is fully compliant with all regulations defined by EudraVigilance and FDA.

Our electronic reporting system allows the expedited reporting to Competent Authorities, as well as the issuance of all regulatory reports. All reports are produced in PDF format.

Regulatory reports:

CIOMS (national version)

Summary tabulation

Line listing

MedWatch 3500A

This report (with regular FDA approval) consists of two different layout. The first one specific for Drug and the other for Medical device.

MedDev Report (initial and corrective version)

Pregnancy form

This report collects data of all the patient pregnancy history with date, periods, children, exposure to radiation, breast info, hospitalization info and so on.

When defining PSURs parametrization, it is possible to insert additional information and memorize defined profiles in the pharmacovigilance database.

Below you can find some report created using SafetyDrugs.

CIOMS report

Summary Tabulation report

Line Listing report

MedWatch 3500A report

Pregnancy form report