Our pharmacovigilance services cover clinical trial support, including adverse event monitoring, safety monitoring plan development, and DSMB support. We manage post-marketing surveillance through real-world safety data management and reporting of post-approval ADRs. Additionally, we provide global safety database management, setting up and maintaining pharmacovigilance systems like Oracle Argus, ArisGlobal, and VigiFlow.
We support global regulatory frameworks including ICH Guidelines (E2B, E2D, E2E), FDA regulations (21 CFR Part 314 and 600), EMA GVP, and guidelines from regions like WHO, MHRA, TGA, PMDA, ANVISA, CDSCO, and GCC. Our technology tools include safety databases like Argus Safety, ArisGlobal, and Veeva Vault Safety, signal detection tools such as Empirica Signal and PV-Works, and coding systems like MedDRA and WHO Drug Dictionary.
We provide comprehensive dossier preparation, including CTD compilation (Modules 1 to 5), eCTD, and paper-based submissions for global markets, supporting dMFs, ANDAs, NDAs, and MAA applications.