Overview
A great drug can be delayed by a bad submission format. We handle the technical complexities of electronic Common Technical Document (eCTD) publishing. We ensure your submission is hyperlinked, bookmarked, and validated against the latest FDA criteria, ensuring a smooth technical screening process.
Key Features
Our Process
Source Review
Checking source documents for formatting and legibility.
Publishing
Building the eCTD structure and linking documents.
Validation
Running validation software to catch and fix errors before submission.
Frequently Asked Questions
Why Choose Us
- Zero technical refusals
- Enhanced reviewer navigation
- Lifecycle management readiness
- Compliance with e-submission mandates
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Schedule ConsultationWhat Our Clients Say
"We had a last-minute CMC amendment that needed to be published in 48 hours. Adelphi's publishing team worked through the weekend and delivered a clean, validated sequence. No technical issues flagged by FDA."
Sandra Williams
Regulatory Operations Director
Biotech Company
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