The CoreX core team
Biologist, Dr. rer. nat.
More than 20 years of experience in regulatory affairs and project management of international multidisciplinary teams within complex regulatory projects.
Focus: working with and advising clients regarding labelling documents (Product Information, Company Core Data Sheets).
Since 2001: Set-up and management of a “Product Information (Labelling) Team” and processes for labelling translations.
Chemist (focus Biochemistry), Dr. rer. nat.
More than 20 years of experience in regulatory affairs and quality management (medical devices and pharmaceuticals), gained as consultant, industry and at a regulatory authority.
Since 12 years labelling expert and project manager for various types of regulatory submissions / authority interactions. Strongly involved in set-up, management and quality related aspects of processes for labelling translations.
Since 8 years regulatory labelling expert. Project lead on all kinds of Centralized Procedures including MAA and all kind of post marketing authorisation procedures within EU/EEA.
When necessary the team will be expanded by involving appropriately trained external resources, most of which have been working as labelling team members in a similar environment previously.