Are you looking for support in creation or implementation of labeling documents?
I will gladly advise your expert teams on regulatory requirements, create documents for you or support you during implementation. My offer comprises for example:
- Creation of Company Core Data Sheets for new developments or products already on the market
- Life cycle management of Company Core Data Sheets
- Evaluation of medical data on your medicinal product for creation of comprehensible product information documents
- Critical review of medical documentation for implementation
- Assignment of Core Safety Information
- Review of national product information documents for compliance of medical content with the Company Core Data Sheet
- Creation or update of EU Summary of Product Characteristics for marketing authorisation applications or update for variations
- Creation or update of EU Package Leaflets (no readability testing!)
- Support of responses to authority requests regarding presentation of medical information
If you have questions on these offers or envisage additional topics, please get in contact for further information!
You decide how many additional resources you need and which part of the project you want to outsource. Usually, I handle your projects online, however, it goes without saying that I am also available for teleconferences or face-to-face meetings in your company, as necessary.