Global and Local Pharmacovigilance Services, since 2008

Local ICSR Management.

Patient safety – everywhere.

We offer complete support for the management of local Individual Case Safety Reports (ICSRs), including but not limited to:

Safety mailbox management.

We can monitor, assess, track, process and forward any correspondence and information received in a local safety mailbox.

Local case submission.

We can process all local submissions to National Competent Authorities according to the applicable country-specific requirements like format, timelines, route of submission, etc.

Case follow-up.

We ensure that all cases that require additional information after initial review are rigorously followed-up back to their sources within any applicable deadlines.