Templates

eCTD documents built on regulatory guidance and industry best-practice

A solid foundation.

Acumen has over 400 eCTD Templates compliant with relevant regulatory guidance (FDA, EMA, PFDA, and ICH), enriched with tips obtained from years of submission writing. 

E-STYLE GUIDE

We’ve built over 400 templates that comply with the most up-to-date regulatory standards (FDA, EMA, PFDA, and ICH) based on the internationally accepted Common Technical Document (CTD).

Core features:

•  Authoring tips added by experienced regulatory writers

•  Links to pertinent regulatory guidance

•  Downloadable via a user web portal 

•  Updated with changes in regulatory guidance

•  Continued real-time access to individual files