What is an eCTD Viewer?

Last Updated: October 2026

What is an eCTD viewer?

An eCTD viewer is software that lets you open an electronic Common Technical Document (eCTD) submission the way a regulatory agency sees it: navigating modules and sequences, reading individual documents, and checking each file's metadata and lifecycle status. Sponsors use one to QC submissions, answer agency questions, support inspections and due diligence, and keep a secure, read-only copy of everything they filed.

In regulatory submissions, efficient document management, accessibility, and compliance are paramount. An eCTD viewer is one of the quieter tools that makes that possible. This article covers what eCTD viewers do, the legal and practical reasons sponsors keep their own, how eCTD 4.0 changes the picture, and what to look for when choosing one.

In this article

1. What does an eCTD viewer do?
2. Do you need your own eCTD viewer?
3. What are the legal obligations?
4. What are the benefits of an eCTD viewer?
5. How does eCTD 4.0 change viewing?
6. What to consider when selecting an eCTD viewer
7. How Kivo handles eCTD viewing, and how the options compare
8. FAQ

What does an eCTD viewer do?

eCTD viewers come with several features that make submissions easier to access and use. Common ones include:

1. Document navigation: Users can browse the sections and subsections of the submission, including the module structure and individual documents.
2. Document viewing: The viewer displays the content of each document in the submission, often with zooming, text search, and highlighting for efficient analysis.
3. Metadata and lifecycle tracking: Viewers display metadata for each document, such as document type, version, submission date, and author, and indicate its lifecycle status within the submission, such as "new," "replace," or "delete."
4. Hyperlinking and cross-referencing: Viewers typically support hyperlinks within the submission, so users can move quickly between related documents and sections.

Do you need your own eCTD viewer?

Most sponsors rely on Contract Research Organizations (CROs) or regulatory operations vendors to build and submit their eCTD sequences. The vendor usually provides a viewer for Quality Assurance/Quality Control (QA/QC) before the submission goes to the agency, but the sponsor should keep its own copy of the eCTD for compliance and inspection purposes. With its own viewer, a sponsor keeps a complete, secure, orderly record of every sequence it has filed, independent of any vendor relationship.

What are the legal obligations?

Agency requirements

Since 2017, the FDA has required commercial NDAs, ANDAs, BLAs, and commercial INDs to be submitted in eCTD format, including every later amendment, supplement, and report (FDA). Sponsors must also retain a copy of what they send the agency, as required by regulations such as 21 CFR Part 312 and 21 CFR Part 11 for the US FDA. Inspectors may ask to review electronic records, so those records need to live in a secure, read-only environment. Agencies in other regions, including the UK, EU, and Health Canada, may inspect records tied to clinical trial applications or market authorizations in the same way. Secure, limited access to the submission streamlines inspections.

Mergers, acquisitions, and partnerships

Many companies partner or merge with other pharma and biotech organizations, for example to out-license a product. These deals require due diligence, which includes a review of past regulatory activity. The submission history of a drug or biologic is material information, and the buyer needs to see it in a secure, read-only format. The review typically covers:

1. All intellectual property, including products on the market and in development.
2. Products under development and their regulatory statuses.
3. Filed and approved marketing applications in the U.S. and abroad.
4. Drug master files (DMFs) filed by the company, plus DMF deficiency letters, annual update reports, authorized references, and related FDA correspondence.
5. Investigational New Drug (IND) application records, including IND numbers, FDA deficiency letters, and correspondence on acceptances or denials.
6. Statuses of foreign and domestic marketing applications, including NDAs, ANDAs, PLAs, and BLAs.
7. Correspondence with agencies on marketing applications, plus records of compliance with filing, Prescription Drug User Fee Act, reporting, and post-market or Phase IV obligations.

Reviewers should see only the correct submission for the correct drug. A viewer that limits access to a single product eases the process and keeps control of the documentation, and an audit trail records who accessed which document and when.

What are the benefits of an eCTD viewer?

During review of a clinical trial or marketing application, agencies may ask for more information or clarification, and finding the relevant content fast is crucial for a timely response. An in-house viewer lets users locate the exact document in question and any linked content. If a document references a section of a protocol, for example, both may need changes. Across multiple sequences, the viewer traces a document's history through its lifecycle, which keeps responses accurate. Viewing the submission as the agency does is the fastest way to respond to a request for information.

How does eCTD 4.0 change viewing?

As regulators move to eCTD version 4.0, the way submissions are viewed changes. Today, a reviewer can open the index.xml file in a browser with a style sheet. Version 4.0 does not use a hierarchical structure or ship a style sheet for human readability, so software has to "render" the XML into something people can read. The XML context and keywords carry information such as module, section, and study ID, and sponsors gain control over document ordering within the submission.

The transition is already underway. The FDA has supported voluntary eCTD v4.0 submissions to CDER and CBER for new NDAs, BLAs, ANDAs, INDs, and master files since September 16, 2024, and has said it will give advance notice before it supports v4.0 only (FDA). At a February 2026 session, regulators indicated that v4.0 will become mandatory for EU centrally authorized products in 2027 and for the FDA by 2029 (RAPS). Check each agency's current timeline before planning, since these dates continue to move.

What to consider when selecting an eCTD viewer

When choosing a viewer, evaluate your requirements against these factors:

1. Integration with existing systems: Check whether the viewer connects to an electronic document management system (EDMS) or publishing system for a seamless workflow.
2. Access and user permissions: Decide who needs access, and confirm permissions can limit users to specific content, such as a single product.
3. Types of views supported: Look for cumulative, sequence, module, and search views.
4. User community support: Confirm the viewer works on the operating systems your users have, is easy to use, and is cloud-based if you need flexible access.
5. Compliance and validation: Verify the viewer meets the electronic-records regulations in your region, provides an audit trail, and controls user permissions.
6. eCTD 4.0 readiness: Ask whether the tool can render v4.0 submissions alongside v3.2.2 ones.

How Kivo handles eCTD viewing, and how the options compare

Kivo's eCTD Viewer is part of Kivo RIM. It is browser-based with nothing to install and works on Mac and PC. It links live to the Kivo document management system, so each document's metadata and audit trail are one click away, and it supports sequence, current, and cumulative views with view-only access you can grant or revoke. It supports eCTD 4.0, and the eCTD format it displays is accepted by the FDA, EMA, PMDA, Health Canada, Swissmedic, TGA, HSA, and MFDS. Kivo does not publish eCTDs itself: it prepares submission-ready packages for your publishing partner and keeps submitted eCTDs viewable and linked to source documents. For more on publishing and validation tools, see What eCTD Publishing and Validation Tools Should Include.

Several vendors offer eCTD viewing or archiving, usually as part of a broader regulatory suite. The table below summarizes how Kivo and three tracked alternatives handle it, based on each vendor's own published materials.

This table is not an independent ranking. It does not assess implementation quality, market share, or fit for any particular organization, and capabilities change, so confirm details with each vendor and validate against your own requirements.

FAQ

What is an eCTD viewer used for?

An eCTD viewer is used to open, navigate, and review eCTD submissions the way an agency does. Sponsors use it for QA/QC before and after filing, to answer agency questions, to support inspections and due diligence, and to keep a secure, read-only record of every sequence.

Does the FDA require a specific eCTD viewer?

No specific product is named. The FDA requires commercial NDAs, ANDAs, BLAs, and commercial INDs to be submitted in eCTD format and expects sponsors to retain their submission records. How you view and store those records is up to you, as long as it is secure, compliant, and inspection-ready.

What is the difference between an eCTD viewer and eCTD publishing software?

Publishing software builds, validates, and packages the submission for transmission to the agency. A viewer lets people open and read a finished submission, including its sequences and lifecycle history. Some suites bundle both, while others handle only one.

Will my eCTD viewer work with eCTD 4.0?

Not automatically. Version 4.0 has no style sheet for human readability, so software must render the XML. Ask any vendor whether their viewer renders v4.0 submissions alongside v3.2.2 ones, and how they plan to follow each agency's timeline.

Conclusion

An eCTD viewer gives organizations transparency, access, and control over their regulatory submissions. Easy navigation, metadata tracking, and complete document viewing streamline QA/QC, meet compliance requirements, support due diligence, and prepare teams for eCTD 4.0. Combined with an EDMS, a viewer becomes an indispensable tool for regulatory and executive teams managing submissions, answering agency requests, and staying compliant throughout the regulatory journey.