吃瓜爆料

Registrations allows sponsors to plan, track, and report on global product registrations along with health authority correspondence and commitments.

Events provide the ability to manage product changes, from the initial assessment of the proposed change through submission creation, health authority interactions, and final registration update. Label changes can be tracked and managed at both the global and local level. Registrations also produces compliant product data output (e.g., xEVMPD and IDMP) for EU regulations.

Dashboards and reports allow personnel to track the progression of change events and provide an understanding of product registration locale.