SciencePharma offer service "PHARMACOVIGILANCE"

SciencePharma has built a complete pharmacovigilance system aligned with Good Pharmacovigilance Practices (GVP), covering all quality dimensions, and makes it available to clients as full or partial services. The experienced team delivers comprehensive individual case safety report management (intake, tracking, processing, MedDRA coding, medical review, follow-up, reporting), signal detection, PSUR preparation and timely submission to authorities, addenda to the clinical overview, weekly literature searches, MAH registration with EudraVigilance, a responsible person for EudraVigilance activities, electronic reporting to EMA and national authorities (via EVWEB or company gateway), and product information maintenance.