Learn how our industry-leading submission authoring solution facilitates efficient creation of submission-ready regulatory documents compliant with International Conference on Harmonization (ICH) and regional structure and formatting requirements.
Drug and device templates
450+ Common Technical Document (CTD) and 100+ medical device templates.
Custom toolbar integrated into Microsoft Word.
CTD specific design
Predefined heading styles, fonts, margins and table formats.
Pre-set validation and compliance
Advanced document validation, Physician Labelling Rule (PLR) functionality, and reference management and 100+ medical device templates.