Do you intend to overhaul your global labeling system or create a new concept?

I will gladly advise you on the questions you select, for example:

  • Components of a global labeling system, processes and guidance
  • Role of the Company Core Data Sheet in the pharmacovigilance responsibility of the pharmaceutical enterprise
  • Structure and function of Company Core Data Sheets, guidance for creation of content and transfer of medical information in  national product information
  • Company-internal monitoring systems for harmonised labeling worldwide (with focus on safety-relevant information)
  • Interaction between company headquarters and local units
  • Complex labeling or regulatory situations

If this description appeals to you, but also if you have other ideas, let us talk about it!

Consulting dialogue is of course fully dedicated to the questions and intention of the client. My contribution to these discussions aside from my medical expertise is based on longstanding experience in large pharmaceutical companies and continuous exchange with peers in the labeling area. Consulting comprises mainly the areas of labeling, interface to pharmacovigilance, risk communication and system evaluation.

My clients are mainly pharmaceutical companies. However, I am also willing to advise other consultants who need specific labeling expertise. These comprise for example non-labeling-specialised consulting companies for drug regulatory affairs as well as software companies who intent to develop labeling software systems.