Symogen
From Verify.Wiki
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.
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Type | Private |
Founded | 2007 |
Headquarters | Metropark, New Jersey |
Key people | Tobby Simon
Founder and Chairman |
Number of employees | 51-200 |
Contents
About
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); PPs
- 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
Specialties
Pharmacovigilance, Pharmacoepidemiology, PSUR/PBRER, Case Management, Signal Detection, EU RMP, REMS, PIPs, Pharmacovigilance Audit/ Inspections, QPPV Services, Medical Writing, Pharmacovigilance Labelling CCDS, SmPCs, IB, Pharmacovigilance Training, and Regulatory Affairs
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