Overview
Technical validation is the final checkpoint before your submission reaches health authorities. Using FDA-compliant validation tools, we verify that every aspect of your eCTD meets technical specifications—from XML backbone structure to PDF formatting to file naming conventions. Our rigorous validation process catches issues that could cause gateway rejections or filing delays, ensuring your submission is accepted on the first attempt.
Key Features
Our Process
Automated Validation
We run the eCTD through FDA-approved validation software to check all technical specifications.
Error Analysis
We review any validation findings, categorizing by severity and determining required corrections.
Issue Resolution
We work with you to resolve any identified issues before final submission.
Final Certification
We provide a validation report certifying the submission meets all technical requirements.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Zero technical rejections from health authorities
- Confidence in your submission quality
- Issues identified and resolved before filing
- Complete documentation for your records
- Faster processing by regulatory agencies
Get More Details
Request a personalized consultation and detailed information about this service.
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for Technical Validation.
Schedule ConsultationWhat Our Clients Say
"We had a tight PDUFA deadline and couldn't afford any gateway issues. Adelphi's validation process caught several problems that would have caused rejections. Their technical rigor gave us confidence to submit on time knowing the package was clean."
Mark Thompson
Director of Submissions
Pharmaceutical Company
Related Services
Explore other ways we can support your regulatory needs
eCTD Compilation & Publishing
Expert compilation in eCTD format (v3.2.2 and v4.0), ensuring compliance with FDA, EMA, and ICH specifications.
IND/NDA/BLA Submissions
Complete publishing services for investigational and marketing applications.
FDA Gateway Transmission
Secure transmission via FDA Electronic Submissions Gateway (ESG) with confirmation tracking.