
according to the current legislation
PHARMACOVIGILANCE
Outsource your
complete pharmacovigilance system
Human
drugs
Veterinary
drugs
Medical
devices
Cosmetics
Food
supplements
or choose
the service you need individually:
24/7 phone service
Pharmacovigilance telephone 24 horus / 7 days a week
Bibliographic searches
Bibliographic searches in different databases (PubMed, IBECS, MEDES, local journals) to detect Adverse Events
Pharmacovigilance audits
Development of pharmacovigilance audits and tactical, strategic and operational planning
SOPs
Elaboration, update review and development of Standard Operating Procedures (SOPs)
Data entry
Data entry in the clients’ data base (Argus)
PSMF
Development and maintenance of the pharmacovigilance system master file
Cases downloads
L2A and MLM cases downloads from Eudravigilance
Report writing
Drafting of risk-management plans (RMP), periodic safety update reports (PSUR) and Addendum to clinical overview

Medical support
We have physicians on our team to carry out the medical evaluation of your cases, as well as the preparation and signing of safety reports for your drugs (Addendum to the clinical overview).
+
0
spontaneously reported
cases per year
cases per year
+
0
PV calls a year
+
0
SOPs review & developed
per year
per year
+
0
Signal Detection Reports
per year
per year