The Variation Toolbox serves as practical helper in the daily work of RA professionals. While the Variation Fee Calculator helps to calculate authority fees across the EU 27, EMA, CH, IS, NO, UK (national/CMS), and RS, the Variation Classification allows for fast access to specific changes within the Variation Classification Guideline. Workload planning is also possible, and Guidelines and Q&A documents are easy to search.
The Guided Workflow is a cross-functional process that can also be used to calculate RA workload, timelines and fees for single and grouped variations as well as for worksharing procedures. When using the Guided Workflow, please note, that some authorities charge slightly different fees for worksharing; this has not yet been taken into account for all countries.
The Variation Toolbox was created entirely using AI (Claude Code).
If you have any idea for other helpful RA tools, comments or suggestions for improvement, please let me know.
info@pharmazulassung.de