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.