Major Drugs - Bourne End, Buckingham, US
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 servicesQPPV Services Medical Device Vigilance; CosmetovigilanceSignal detection, analysis and evaluationProduct Risk Management (RiskMAPs; REMS and RMPs);PIPsPharmacovigilance systems ValidationData Migration from Oracle AERS, ClinTrace, Safety Easy to ARISg and ARGUSPharmacovigilance Audit (FDA, EMA, MHRA and other EU Regulatory Agencies)ICSR Processing and Management for Clinical Trials and Post-Marketing 24/7/365PSUR/PBRER/PADER/DSUR preparationHarmonisation of SmPC, IB, CCDS for Labelling Set up of RegistriesConduct of PASS StudiesMedical WritingRegulatory Services
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