How CMCfy turns raw data into a reviewed CTD section.
CMCfy does the arithmetic and the checking. Your people still read, justify and sign.
Steps
Four steps from your files to a CTD section
- Load what you already haveResults tables, the protocol, batch records or last year's section. Excel, CSV, Word, PDF and scanned pages all work.
- Pick US, EU or bothThe checks and references switch with the region: USP or Ph. Eur., FDA guidance or EMA guidelines.
- Read the reviewBefore anything is exported you see the draft with every gap listed: missing data, missing content and differences from your protocol.
- Download the sectionWord or PDF, one file per CTD section, and a summary file the QOS Composer uses so Module 2.3 agrees with Module 3.
Reads .xlsx .xls .csv .docx .doc .pdf, scanned PDF, .jpg .png .tif, .odt .ods .rtf .pptx
The review
Every export opens a gap review against the guideline first
When you click download, the document opens in a preview with three lists beside it.
- Gaps in the dataTests, lots or results the guideline expects but your data doesn’t include.
- Gaps in the reportPlaceholders left in, checklist items missing, references for the wrong region.
- Differences from the protocolEach requirement and acceptance criterion in your protocol is looked for in the report.
A major finding has to be fixed or justified in writing before the file is exported. If you want it, the optional AI review reads the draft as a reviewer would.
US and EU
One dataset, written for FDA and for EMA
Switch the region and the same section is rewritten with the references each agency expects. Pick both for a global dossier.
United States FDA
- Endotoxin method
- Bacterial endotoxins, USP <85>, NMT 0.20 EU/mg
- Manufacturers (P.3.1)
- Each site with its FDA Establishment Identifier (FEI)
- Process validation
- PPQ before commercial distribution, per the FDA Process Validation guidance (2011)
- Regional information (3.2.R)
- Executed batch records, method validation package, comparability protocols
European Union EMA
- Endotoxin method
- Bacterial endotoxins, Ph. Eur. 2.6.14, NMT 0.20 EU/mg
- Manufacturers (P.3.1)
- EEA batch release site with a Qualified Person, and GMP certificates
- Process validation
- Process validation scheme in 3.2.R, per the EMA process validation guideline
- Regional information (3.2.R)
- Process validation scheme, CEP or ASMF, medical device (Art. 117), TSE certificates
The numbers
ICH calculations you can check by hand
Pass/fail results come from fixed rules that cite the guideline, never from AI. We test the Q1E statistics against SciPy, and our test suite runs each module's worked example through its own review for both regions.
Specifications checked against ICH Q6A
Nine tests and five impurity limits checked against Q6A and Q3B(R2), with the identification and qualification thresholds worked out from the maximum daily dose.
Judge it on a section you already wrote
Paste a section into the Report Reviewer and read what it finds. Nothing you paste leaves your computer.