StartingPoint submission authoring suite

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.

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Connect with us

Outside US

Contact Andy Gerrard
1(571)434-5003

StartingPoint customers

If you’re an existing customer and have product questions or need details on StartingPoint.

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Our leaders