Local ICSR Management

Local ICSR Management.

Patient safety – everywhere.

We offer complete support for the management of local 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 CAs 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.

Selected PV Case Studies.

View all
ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
Local PV, regulatory strategy
Complex pharmacovigilance local support