Pharmacovigilance services

The introduction of the new Pharmacovigilance legislation has been a turning point for the European pharmaceutical industry, establishing standards which pose difficulties especially to mid-size and small market players.

We have the active experience of supporting our clients in achieving compliance with the new Pharmacovigilance legislation.

Our range of expertise covers the entire scope of the GVP, from the establishment and maintenance of Pharmacovigilance Systems, through writing of Risk Management Plans and Periodic Safety Update Reports, until design and management of Post-Authorization Safety Studies.