Overview
Before documents can be compiled into an eCTD, they must meet specific technical requirements for format, structure, and quality. Our document management services ensure every document in your submission is properly formatted, hyperlinked, bookmarked, and validated. We catch and correct issues before they become problems, ensuring your submission presents a professional, reviewer-friendly package to health authorities.
Key Features
Our Process
Document Receipt
We receive source documents and log them into our document management system.
Technical Processing
We convert, format, and optimize documents according to eCTD specifications.
Quality Review
Each document undergoes multi-level QC for technical compliance and quality.
Issue Resolution
We identify and correct any issues, returning documents ready for eCTD compilation.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Documents that meet all technical specifications
- Enhanced reviewer experience with proper navigation
- Consistent formatting across your submission
- Reduced risk of technical issues or delays
- Quality documentation for your regulatory files
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Schedule ConsultationWhat Our Clients Say
"The documents we received from our clinical sites were a mess—inconsistent formatting, broken links, missing bookmarks. Adelphi's document team transformed them into a professional, navigable submission. Their QC work was outstanding."
Linda Chen
Regulatory Publishing Manager
Contract Research Organization
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