eCTD Compilation & Publishing
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eCTD Compilation & Publishing

Technical Excellence for Your Regulatory Submissions

Overview

The electronic Common Technical Document (eCTD) is the mandatory format for regulatory submissions to FDA and other major health authorities. Proper eCTD compilation requires specialized knowledge of technical specifications, regional requirements, and validation rules. Our publishing team has compiled thousands of successful eCTD sequences, ensuring your submissions are technically compliant and reviewer-friendly. We support both eCTD v3.2.2 and the newer v4.0 format.

Key Features

Full eCTD lifecycle support (original, amendments, supplements)
eCTD v3.2.2 and v4.0 format expertise
Multi-region compilation (FDA, EMA, Health Canada, etc.)
Document granularity and structure optimization
Hyperlinking and cross-referencing
XML backbone generation and validation

Our Process

1

Document Receipt

We receive your source documents and conduct an initial assessment of publishing readiness.

2

eCTD Assembly

We structure documents according to CTD format, applying proper granularity and creating the eCTD backbone.

3

Quality Control

We validate the submission package using industry-standard tools and conduct internal QC review.

4

Delivery

We deliver the validated eCTD package ready for gateway transmission or provide full submission services.

Project Complete & Deliverables Provided

Frequently Asked Questions

eCTD v4.0 is the newer specification that offers improvements in submission management and is required by some regions (notably the EU). v3.2.2 is still accepted by FDA. Key differences include the XML schema, handling of document references, and lifecycle management. We're proficient in both and can advise which version is appropriate for your submission.

Why Choose Us

  • Zero technical rejections from health authorities
  • Submissions optimized for efficient regulatory review
  • Proper lifecycle management across sequences
  • Consistent quality across all your submissions
  • Reduced internal burden on your regulatory team

Get More Details

Request a personalized consultation and detailed information about this service.

Personalized consultation
Detailed service information
Custom timeline & proposal
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We'll respond within 24 hours

Ready to get started?

Contact our team to discuss your specific needs for eCTD Compilation & Publishing.

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What Our Clients Say

"Our internal team didn't have eCTD expertise, and we needed to submit quickly. Adelphi's publishing team turned around a complex IND in under two weeks with zero validation errors. Their eCTD work was impeccable."

Dr. Elizabeth Grant

Regulatory Director

Emerging Biotech

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