The overview of the consultancy and services are continuously updated. If you do not find exactly what you are looking for, just contact me
- I'll be pleased to help.
Pharmacovigilance- advisory and supporting services for development compounds and established products
Compilation and maintenance of the Pharmacovigilance System Master File (PSMF)
Implementation of national / international legal pharmacovigilance requirements (e.g. ICH, Good Pharmacovigilance Practices / GVP)
Developing and establishing company-internal global PV standards
Setting-up / Optimizing PV systems in affiliates
Development and revision of process descriptions (SOPs, WIs) and templates
Taking over of interim positions
Strategic PV planning
Support in resource management and recruitment
Support in budget and cost centre planning / maintenance
European Qualified Person for Pharmacovigilance, EU QPPV (or Deputy)
German Graduated Plan Officer acc. to §63a German Drug Law (or Deputy)
Cumulative signal detection and evaluation
Benefit-risk assessments of medicinal products
Setting up Risk Management Plans (RMPs) and Risk Minimization Measures
Support in / Management of medical alert situations
Preparation and follow-up Health Authority Inspections / Audits incl. CAPA development
Support in handling Health Authority deficiency letters, European risk procedures (referrals)
Distinction issues (medicinal products, medical devices, cosmetics)
Since this overview can’t capture the entire consultancy and service package, don't hesitate tocontact mefor more detailed information and an individual offer tailored to your particular situation.