Our safety officers are certified users of the EudraVigilance web-based reporting tool (EVWEB). You can use us as an external pharmacovigilance department, or as a back-up solution during periods of holiday or sick leave. We are also happy to perform one-off pharmacovigilance tasks.
- Spontaneous and periodic reporting of adverse events
reporting (EudraVigilance, EudraVigilance Veterinary)
- Registration of product information in the XEVMPD
- Literature searches – local and worldwide
- Medical coding (MedDRA, VedDRA)
- Medical evaluation
- Pharmacovigilance System Master File
- Risk Management Plan
- Standard operating procedures
- Signal detection and evaluation
Adverse event management
Use our experience in national and international
drug safety reporting in clinical trials and post-marketing. You can count on
us all the way from receipt of initial data through to regulatory reporting. We
are familiar with commercial databases and have certified users of EVWEB.
Development safety update
report (DSUR) / annual safety report
Get all the help you need to compile and submit
annual safety reports to competent authorities and ethics committees.
Periodic safety update reports
Benefit from our experience in writing PSURs on
therapeutic products and diagnostics.
Let our certified users submit individual case
safety reports (ICSRs), suspected unexpected serious adverse reactions (SUSARs),
and serious adverse events in animals electronically to EudraVigilance and
EudraVigilance Veterinary using EVWEB.
Registration with EudraVigilance
We have registered several companies with
EudraVigilance. Both companies with marketing authorisations for medicinal
products for human and veterinary use, as well as a number of commercial and
non-commercial sponsors of clinical trials.
Registration of product information in XEVMPD
Our certified users of EVWEB can
register and update your product information in the XEVMPD.
Get worldwide literature screening for safety
data on pharmaceutical products. As a Scandinavian contract research
organisation (CRO) we can also screen local journals in Norway, Sweden and
can prepare or assist you in the preparation and updating of the Pharmacovigilance
System Master File.
Let us prepare your SOPs. We regularly undertake
this on behalf of pharmaceutical companies on both a local, as well as global,
We can assist you with your internal training
requirements, as we provide training programmes in all aspects of