Symogen Limited

Symogen Ltd. is a leading pharmacovigilance, pharmacoepidemiology, medical writing and regulatory affairs service provider to the pharmaceutical industry with offices in the UK, USA and India. Symogen Ltd provides the following services: Functional Service Provider for All aspects of Pharmacovigilance, Pharmacoepidemiology, Medical Writing & Regulatory services QPPV Services Medical Device Vigilance; Cosmetovigilance Signal detection, analysis and evaluation Product Risk Management (RiskMAPs; REMS and RMPs);PIPs Pharmacovigilance systems Validation Data Migration from Oracle AERS, ClinTrace, Safety Easy to ARISg and ARGUS Pharmacovigilance Audit (FDA, EMA, MHRA and other EU Regulatory Agencies) ICSR Processing and Management for Clinical Trials and Post-Marketing 24/7/365 PSUR/PBRER/PADER/DSUR preparation Harmonisation of SmPC, IB, CCDS for Labelling Set up of Registries Conduct of PASS Studies Medical Writing Regulatory Services