DMF & ASMF

1. What this module does

You enter the holder, the US DMF and EU ASMF references, the versions of each part, the sections with their part, the specification and impurity information given to the applicant, the letters of access and the changes since the last version.

The tool checks each section is in the right part, that sections the applicant must see are in the applicant's part, that both parts carry the same version, that customers are notified of changes, and gives the US annual update due date.

What you get

• A Word or PDF report: section allocation, letters of access and the change summary for the annual update or new version.

2. Before you start

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

• Holder and US agent, DMF number and date, ASMF reference and versions.
• The section list with the part and version.
• Letters of access and changes since the last version.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/dmf-asmf.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 master file

   Choose the regions, enter the holder, agent, DMF number and date and the ASMF reference and versions.

   

2. Allocate the sections

   One row per section with AP (applicant's part) or RP (restricted part).

3. Read the result

   The headline counts the sections in each part: "13 sections in the applicant's part · 6 in the restricted part". The note says whether the versions match and when the US annual update is due.

   

4. Resolve alerts and download

   Misallocated or missing sections, a specification or impurity information missing from the applicant's part, mutagenic and nitrosamine statements, version mismatch, missing GDUFA assessment, a foreign holder with no US agent and customers not notified are flagged. Then preview and download.

   

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 · Master file

2 · Section allocation

Part: AP (applicant's / open part), RP (restricted / closed part) or both.

3 · Customers and letters of access

5. Checks and alerts

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

• Sections the applicant needs (specification, impurity profile, stability) are in the applicant's part.
• Applicant's and restricted part versions match.
• US annual update due date (one year from the DMF date or last update); GDUFA fee and completeness assessment for ANDA use; US agent for a foreign holder.
• Letters of access for each customer and customers notified of changes.

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: Cover letter text. 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

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 follows 21 CFR 314.420 and the FDA DMF guidance. EU follows the ASMF procedure guideline (CHMP/QWP/227/02 Rev. 4).

8. Working with other modules

• The applicant references the master file in the Regional Information (3.2.R and Module 1) module.

9. Common pitfalls

• Updating one part without the other.
• Putting the specification only in the restricted part.

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. Update one part only

   Set Restricted part version to RP-02 (2025-01).

   Expected resultThe note says the two parts carry different versions.