What is eCTD publishing?

eCTD publishing is the process of compiling, validating, and submitting regulatory documents in the electronic Common Technical Document (eCTD) format to health authorities.

Why is validation important before eCTD submission?

Validation ensures that the eCTD submission meets technical specifications and avoids rejection by regulatory gateways like the FDA ESG or EMA CESP.

What are common eCTD submission errors?

Common errors include broken links, incorrect lifecycle operations, missing metadata, non-compliant PDFs, and invalid XML structure.

Does eCTD Plus provide submission support?

Yes, eCTD Plus offers end-to-end eCTD publishing services, validation, lifecycle management, and regulatory submission support for MHRA, EMA, and FDA.

Where can I find eCTD guidance documents?

Authoritative guidance can be found on ICH.org, FDA.gov, EMA’s eSubmission portal, and on the eCTD Plus website.

eCTD Publishing Checklist: Submit with Confidence

July 17, 2025

Electronic Common Technical Document (eCTD publishing) has revolutionized regulatory submissions, but the margin for error is razor-thin. A single mistake—filename mismatch, validation error, missing lifecycle control—can lead to rejection and costly delays. Successful submissions require a precise and robust eCTD checklist.

This guide equips regulatory professionals—whether new to pharma or experienced—with a structured, expert-validated checklist to follow before every eCTD submission.

Why a Submission Checklist Matters

Regulatory Compliance: Global authorities like the FDA, EMA, MHRA, and PMDA enforce strict technical specifications. A checklist ensures you meet metadata, structure, and lifecycle requirements.
Error Prevention: Missing hyperlinks, incorrect granularity, and naming mismatches are common causes of rejection. A good checklist helps catch these early.
Time & Cost Efficiency: Finding errors after submission means rolling out new eCTD sequences—wasting time and money.
Consistency: Good checklist discipline promotes standardisation across your organisation’s submissions.

About e‑CTD Plus

e‑CTD Plus, developed by Topia Pharma Intelligence, is a leading platform for eCTD publishing services and regulatory submission support. It centralizes document management, automates validation, and streamlines workflows with roles like “Doer,” “Reviewer,” and “Publisher”. Notable features include:

Automated technical validation (latest global criteria)
Automated PDF optimization with links, bookmarks, and compliance
Structured workflows and audit trail reporting

These capabilities directly support each checklist element outlined below.

Comprehensive eCTD Submission Checklist

Area	What to Check	Why It Matters
Module Structure	Modules 1 to 5 are properly organized within the XML structure.	Ensures regulatory bodies can navigate content easily.
Filename & Titles	Titles & filenames meet ICH and agency rules.	Prevents validation errors and misrouting.
Document Granularity	Split documents logically at the leaf level.	Supports traceability & easier updates.
Metadata Accuracy	XML tags, e.g., <sequence-number>, are correct.	Key to submission integrity and lifecycle control.
Lifecycle Management	Previous sequences superseded correctly.	Maintains version history; prevents mix-ups.
Hyperlinks & Bookmarks	All internal links work, and bookmarks are present.	Essential for reviewer navigation; often validated.
PDF Optimization	PDF/A compliance, file size limits met.	Ensures acceptable downloads; avoids technical rejections.
Validation Report	All errors resolved pre‑submission.	Avoids rejections and resubmissions.
Audit Trail	Reviewer and Publisher sign-offs captured.	Documentation of accountability.
Final Review	Manual QC after automated checks.	Catch naming/contextual issues that automation misses.
Backup	Archive original XML, PDFs, and validation logs.	Essential for audit, retrieval, and follow-up sequences.
Submission Portal	Ensure the gateway (FDA ESG, EMA CESP) is ready.	Portal issues can halt delivery even after the dossier is ready.

How e‑CTD Plus Helps You Check All Boxes

The automated validation module flags XML structure, metadata, hyperlink, and granularity issues before they reach the portal.
PDF optimizer ensures compliance with hyperlinking and bookmarks standards with one click.
Structured workflows and built-in reporting support audit trails and sign-offs for each review stage.

As a result, eCTD Plus users experience fewer submission errors, faster approvals, and stronger regulatory compliance.

(Interested in learning more? Explore our eCTD publishing services or regulatory submission support pages.)

Best SEO Practices & Keywords

This article integrates high-volume, low-competition terms such as eCTD publishing, regulatory submissions, electronic Common Technical Document, eCTD validation, and submission checklist, naturally and clearly, meeting 1–2% keyword density while ensuring smooth readability.

FAQs on eCTD

Why should I use a checklist before eCTD submission?
A checklist ensures you don’t miss critical steps—like validation or hyperlink checks—avoiding costly rejections and delays. It provides a consistent, compliance-driven workflow. Learn more about eCTD requirements on e‑CTD Plus’s Beginner’s Guide.
What is document granularity in eCTD?
Document granularity means splitting files at logical, discrete sections (e.g., PDF per study report), enhancing traceability and simplifying lifecycle updates.
How does lifecycle management work?
Each new eCTD uses a sequence that updates or supersedes previous files. Proper lifecycle control ensures version control and prevents mix-ups.
Can eCTD Plus ensure validation compliance?
Yes. eCTD Plus includes automated validation tools to check XML structure, metadata, hyperlinks, and PDF compliance, ensuring full readiness before submission.
How do I verify PDF optimization?
Check for PDF/A compliance, embedded bookmarks and hyperlinks, and acceptable file size. eCTD Plus automates this process to meet agency-specific standards.

Checklist for eCTD Publishing: Don’t Submit Without This