Your partner for pharmacovigilance

Our services

Our main focus is providing pharmacovigilance consulting services, including PV audits, gap analysis and closure for the client's PV system on a global level, as well as PV trainings. As a full-service pharmacovigilance CRO, our services include but are not limited to:

 - Case processing including data entry, medical review, QC, submissions globally

- Aggregate report preparation (DSURs, PSURs, PBRERs, ASRs, PADERs)

- Literature screening for both ICSRs and aggregate reports

- EU and global Qualified Person for Pharmacovigilance (QPPV) services

- Review, update and preparation of PV SOPs

- PV QMS audits and gap analysis and closure, CAPA resolution

- PV Trainings, both in general and client-tailored

- Global risk management activities (RMP/REMS planning, writing and execution)

- Medical Information services