General pharmacovigilance consultancy
Assistance in drawing up of SOPs for pharmacovigilance
Implementation of pharmacovigilance systems
Local pharmacovigilance representation
Communication with regulatory authorities
Receipt, revision and validation of adverse events (AE) and adverse reactions (ADR)
Processing of adverse events and adverse reactions in a validated database compliant with FDA 21 CFR part 11
Notification of regulatory authorities regarding adverse events and adverse reactions
Codification of adverse events (MedDRA)
Bibliographical search to obtain medication safety information
Preparation and submission of periodical safety update reports