eCTD, or electronic common technical document filing, is the standard submission format for FDA regulatory application submissions. AO Regulatory Consulting offers the following publishing services for all submissions to FDA:
- eCTD-ready templates
- Submission planning assistance
- Submission management and tracking
- Cover letter/FDA Form 1571 generation
- Conversion of Word documents to PDF
- PDF formatting to meet FDA standards
- Internal document bookmarking
- Cross-document hyperlinking
- Review of eCTD output for or with the Sponsor