eCTD
- New eCTD compilation and publishing
- Conversion from existing paper and/or electronic CTD or NtA to eCTD of NeeS format>
- Continued eCTD sequences compilation
- Electronic dossiers paper copies publishing, if needed
PIL Readability Testing
We prepare PIL Readability Testing from 2012 . We have already done 20+ orders which were successfully certified by responsible services in Croatia and neighbouring countries
Service includes:
- Preparation of Patient leaflet under CMD(h) requirements
- Analysis of products portfolio and estimation which products are subject of full testing and for which bridging reports are enough
- Statistical analysis of data from PIL Readability Testing
- Bridging reports preparation
- Final report writing, in English
Marketing materials:
- Graphic editing.
- Compliance with regulations.