The team at Symogen Ltd offer full and customized support for safety department. Our services include the following:

• ~ ICSR Narrative including Company Assessment and Comments ..
• ~ Causality Assessments .
• ~ Risk Benefit Assessments .
• ~ Analysis of Similar Events .
• ~ Integrated Summary of Safety Sections (ISS) .
• ~ NDA Annual Report Safety Sections .
• ~ Clinical Safety Reports.
• ~ Annual and Ad hoc Safety Signal Evaluations .
• ~ Medical assessment and Analysis for PSUR, PADER, ASR, DSUR .
• ~ Position Papers .
• ~ Risk Management Plans (e.g. RiskMaps, REMS, EU-RMP, PIPs) .
• ~ Pharmacovigilance Plans .
• ~ Reference Safety Information Reviews/Revisions (e.g. core label, SmPC, PI, CCDS) .
• ~ Dear Doctor and HCP Letters.