Services
Symogen Ltd can build and maintain the product's safety database specially for small companies thereby ensuring regulatory time lines and obligations are met.
- ~ Updating of Safety Database based on Sponsor approved changes to prescribing information
- ~ Preparation of SOPs and Working Guidance Documents for processes.
- ~ Providing expert and cost effective solutions for Pharmacovigilance systems and processes..
- ~ Liasioning with regulatory authorities EMEA, FDA, MHRA .
- ~ Development and maintenance of Analysis of Similar Events .
- ~ Providing MedDRA Coding and Causality Analysis.