Publishing

Our experienced team and state-of-the-art publishing software offer support for all aspects of electronic submissions in Europe, the US, and the Rest of the World, including compilation and project management of the electronic Common Technical Document (eCTD).

Bookmarks and inter-document hyperlinks

Compilation of CSR Section 14 and 16 appendices

PDF Rendition to eCTD-compliant files

QC and formatting for eCTD compliance

Compilation and publishing eCTD sequences

Technical Validation according to regional criteria

Submission via Agency Gateways

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