ceutico consulting services offer service "Pharmacovigilance"

Provides a full suite of pharmacovigilance services, including PV master file development and maintenance, SOP development, quality management system setup, audit and inspection-readiness support, risk management plan (RMP) development, periodic benefit-risk assessment report (PBRER) preparation, literature searches, ICSR submission, signal management procedures, safety data exchange agreement (SDEA) review, sales-team reporting training, post-authorization safety study follow-up with CROs, and additional risk-minimization materials.