Our services

The design of an efficient pharmacovigilance system is not trivial. We offer you support with a suitable and cost-effective solution for your portfolio.

We carry out an analysis and evaluation of your existing QM system or support you in the implementation of a QMS.

We assume the role of the QPPV or the graduated plan officer and the deputy.

As GVP auditors, we carry out individual audits or entire audit programs - from document audits to system audits on a local or global level. We advise you on risk-based approaches for audit programs and support you in the implementation. Following audits or inspections, we support or take over the management of CAPAs and support you in the coordination with relevant interfaces and functions and successful implementation.

We have accompanied many authority inspections together with customers (e.g. EMA, MHRA, BfArM, PEI, MPA, AGES, Swiss Medic, SUKL). We don't just stop at support during the preparation and training measures, we also offer you strategic and organizational support during the inspection itself.

Whether field service training or qualifying training for the QPPV - we offer you all types of pharmacovigilance-related training.

Let us put your processes into words. We offer you the complete service from process definition through implementation to the final SOP.

Audits focus on compliance with internal and external requirements and laws, but the effectiveness of the processes is not evaluated. A positive audit result does not mean that your pharmacovigilance system also works well from an economic point of view. We analyze individual processes or entire systems with regard to possible increases in efficiency so that you can use your existing budget optimally.