Eleven fields in which we have held mandates.
What is described here is the service, not the client — from the assumed QPPV function to the pharmacovigilance audit.
The mandates range from assumed functions — EU QPPV, Graduated Plan Officer, Medically Trained Person — through setting up and updating quality assurance systems to lead auditing, single case processing, medical writing and pharmacovigilance in non-interventional studies. In addition, there are contract services such as training, medical consulting and data entry into pharmacovigilance databases. Whom we supported is deliberately not stated on this page — the type of company, however, is.
Clients included
National and international marketing authorisation holders
Distributors of medicinal products
Research-based pharmaceutical companies
Pharmaceutical and biotech companies from the USA
Specialty pharmaceutical companies from Europe and Israel
Active substance and medicinal product manufacturers
Pharmaceutical start-ups
Pharmacovigilance and regulatory service providers
We do not name our clients. In a pharmacovigilance mandate, confidentiality is not a courtesy but part of the service — which is why this list says what we did, not for whom.
EU QPPV / Graduated Plan Officer
For national and international marketing authorisation holders and distributors of medicinal products.
Graduated Plan Officer under Section 63a AMG
For several American pharmaceutical and biotech companies and for various pharmaceutical and specialty pharmaceutical companies from France, Great Britain, Israel, etc.
Medically Trained Person
For national and international marketing authorisation holders.
Creation of a new PSMF
For national and international marketing authorisation holders.
Update of the quality assurance system
Revision and creation of the pharmacovigilance SOPs, the PSMF, pharmacovigilance contracts and exchange agreements. Client: German affiliate of an international pharmacovigilance and regulatory consulting company.
Lead pharmacovigilance auditor
For national and international marketing authorisation holders, active substance and medicinal product manufacturers.
Pharmacovigilance in non-interventional studies
For one of the world’s largest research-based pharmaceutical companies.
Patient Safety Specialist
For various international research-based pharmaceutical companies.
GVP/GDP Regulatory Consultant
For various pharmaceutical start-ups.
Medical Writing
Pharmacovigilance expert reports for marketing authorisation holders and pharmacovigilance service providers.
Contract services
Training, medical consulting, data entry into pharmacovigilance databases, etc.
- Pharmaceutical companies
- Specialised service providers in Germany and abroad
- IT developers, programmers and database manufacturers (safety database, XEVMPD)
- Physicians and pharmacists
- Industry associations
- Authorities
- Specialised lawyers and consultants
… and an extensive network of experts in pharmacovigilance and regulatory affairs.