Helping pharmaceutical and biotech companies enable greater speed and efficiency in eCTD authoring, reviewing and publishing submission documents.
A head start for pharma and biotech submissions
StartingPoint allows rapid deployment of authoring standards across all functional areas to facilitate efficient formation of submission documents.
Making submission authoring simple
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.