Vigilance
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.

We offer

 

Surveillance

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)

Safety reports

Preparation and submission of annual safety reports (ASRs) and periodic safety update reports (PSURs)

Literature

Local and worldwide search of scientific literature

Database

A world collecting database and integrated safety summaries (MedDRA) with access to Eudravigilance

Qualified person

QPPV person, 24 hours, 365 days

Consultancy

Consultancy and systems analysis

Training

Pharmacovigilance training