Other

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
Lightbox by Lokesh Dhakar