GSS Pharma Services

GSS Pharma Services provides Pharmacovigilance services to Pharmaceutical companies globally at best prices in the industry. Our end-to-end Pharmacovigilance services include but are not limited to: * QPPV assistance. * Global literature monitoring of molecules by using Distiller and Medical literature monitoring from EMA. * Triage, Data Entry, Quality review and Medical review and submission of ICSRs downloaded from Eudravigilance portal, spontaneous cases, and cases from global literature search. * Submission of Risk management plan as part of initial dossier submission and updates to the same. * Preparation and submission of PSUR/PEBRER and EURD list check. * Signal detection and evaluation. * Annual SmPC review for clients. * Update of SmPC in XEVMPD after the receipt of grant from Health Authority. * EMA account management. * Addendum to clinical overview (ADCO) with clinical expert statement.