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Dossier assembly and review · Training guide

eCTD Dossier Planner

Plan an FDA eCTD sequence before publishing: each file placed in its CTD folder, the sections the application type needs, and the technical checks FDA's validation applies.

Writes
eCTD sequence
Product type
Small molecule and biologics
Guidance it follows
ICH M8 eCTD Specification v3.2.2 and eCTD v4.0 Implementation Guide; FDA eCTD Technical Conformance Guide; FDA Specifications for eCTD Validation Criteria; FDA Portable Document Format (PDF) Specifications; FDA Comprehensive Table of Contents Headings and Hierarchy; FD&C Act 745A(a); FDA Providing Regulatory Submissions in Electronic Format (eCTD)
Time to learn
About 20 minutes with the example

Open the tool at https://app.cmcfy.com/app/ectd-dossier-planner.html. This guide is also online at https://cmcfy.com/guides/ectd-dossier-planner.html

1. What this module does

You give the application, sequence and submission type, and one row per file with its CTD section, name, pages, size, PDF version, bookmarks and searchable text.

The tool works out the folder of each file, lists the required sections for an original NDA, BLA, ANDA, IND or DMF, and checks file names, path length, PDF version, size, bookmarks, OCR, duplicates and the sequence and application numbers.

What you get

  • A Word or PDF file: eCTD sequence plan with the table of contents and the technical check findings.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

  • The file list from your publishing folder.
  • Page count, size and PDF version of each file.
  • The application number FDA assigned.
Your data stays on your computer. The bar under the title counts every network request the page makes; it stays at 0 because your data never leaves your computer. Download offline copy saves a single file that opens from your own computer with all network access blocked, for air-gapped PCs.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/ectd-dossier-planner.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

  1. Describe the sequence

    Choose the application type, submission type and eCTD version, and give the application and sequence numbers.

    eCTD Dossier Planner

  2. List the files

    One row per file. Give the CTD section as numbered in the CTD, for example 3.2.P.5.1.

  3. Read the result

    The headline gives the outcome: "3 issues that would fail FDA validation".

    Required sections and file checks.
    Required sections and file checks.

  4. Resolve alerts and download

    Invalid file names, PDF versions outside 1.4 to 1.7, files over 100 MB, duplicate names and missing required sections are critical. Missing bookmarks and text that cannot be searched are flagged. Then preview and download.

    eCTD Dossier Planner

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Application and sequence

FieldWhat to enter
ProductType it in.
Application typeChoose one: NDA; BLA; ANDA; IND; DMF.
Application number (6 digits)Type it in.
Sequence numberType it in.
Submission typeChoose one: Original application; Amendment; Supplement; Annual report; Response to information request.
eCTD versionChoose one: eCTD v3.2.2; eCTD v4.0.
Drug substance folder name (substance-manufacturer)Type it in.
Study tagging files prepared for Module 4 and 5 studies when it appliesTick the box if it applies.

2 · Files

One row per file (leaf). Section as in the CTD, for example 3.2.P.5.1 or 1.14.1. Pages, PDF version and size come from the file properties.

FieldWhat to enter
FilesFile names use lower case letters, digits and hyphens only, for example cmx-101-301-csr.pdf. A table. Columns: CTD section | File name | Pages | Size (MB) | PDF version | Bookmarked (yes/no) | Searchable text (yes/no). Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan).

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

  • File names, path length, PDF version, size, bookmarks and OCR.
  • Required sections by application type.
  • Sequence and application number format.

How to resolve alerts

  • Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
  • Major alerts block the download until you fix them or type a justification and press Accept justification.
  • Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
  • Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Submission note. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

  1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
  2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
  3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
  4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
  5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

SectionDocument
eCTD sequenceeCTD sequence plan and technical check

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US only: FDA eCTD (Module 1 US regional).

9. Common pitfalls

  • Scanned study reports without OCR.
  • Stability reports over 100 MB that need splitting.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

  1. Fix the file names

    Rename Specification_DS.pdf to specification.pdf.

    Expected resultOne fewer issue that would fail FDA validation.