and safety expertise
The vigilance is one of the emerging areas in the plenty of industrial sectors in recent years.
The substantial changes in regulation emphasise the need for a focused
and dedicated approach and a high level of knowledge..
The vigilance used to be marginal issue in many companies. Today represented one of the key drivers of the capacity. But only a professional team fully dedicated to this area can be effective and deliver the required quality.
Pharmacovigilance surveillance of your products:
Reporting of SAEs
Reporting and processing of serious adverse events (SAEs)
Reporting of ADRs
Reporting and processing of adverse drug reactions (ADRs)
Preparation and submission of annual safety reports (ASRs) and periodic safety update reports (PSURs)
Local and worldwide search of scientific literature
A world collecting database and integrated safety summaries (MedDRA) with access to Eudravigilance
QPPV person, 24 hours, 365 days
Consultancy and systems analysis