Pharmacovigilance

Effective processing of clinical trial safety data is imperative to both the successful performance of the study and to guarantee post-marketing safety. NEOX offers effective management of clinical trial and post-marketing adverse events from case assessment to expedition, including processing, expedited reporting, periodic safety update reports (PSURs), literature screening and safety signal detection and review. We also offer services around pharmacovigilance operation:

Regulatory

Our Regulatory Affairs team are local experts who hold vast experience and extensive knowledge in national guidelines and procedures, key aspects of the local regulatory processes, and documenting management practices.

Regulatory Affairs services for marketing authorizations