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.
Microsoft compliance
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.
