Our Services
Atessia Vigilances is here to advice, train, and guide you in understanding and applying all relative regulatory requirements.
EUQPPV/RPV
Management of local responsibilities in France and/or Europe, including oversight of the pharmacovigilance system and activities, and interactions with Health Authorities.
Clinical trials
Pharmacovigilance management for Phases II, III and IV Clinical Trials.
Literature Monitoring for Pharmacovigilance
Monitoring of pharmacovigilance literature in local French and/or international sources. Regulatory Intelligence monitoring of Health Authority requirements.
Pharmacovigilance and Other Vigilance
Adverse Reaction Management / Incident notifications from initial receipt to submission.
Safety Data Services
PV Database Management, EUDRAVIGILANCE registration.
Call Management
Handling all calls, both during and outside office hours, related to pharmacovigilance, medical information, product complaints and more.