Built by CMC scientists who got tired of checking the same things by hand.
A Module 3 section is mostly arithmetic and cross-checking. Does the shelf-life claim follow from the data? Is every Q6A test in the specification? Does the QOS quote the same numbers as the section? CMCfy does that part, so your experts can spend their time on judgement.
How we build it
Four rules we don’t break when we build CMC software
Your data stays with you
Unpublished CMC data should not have to go online to be useful. Every module runs on your own computer.
Rules before AI
Numbers and pass/fail results come from fixed calculations that cite the guideline. AI only helps with wording, and only when you ask.
Experts decide
CMCfy drafts and flags. Your qualified people review, justify and sign.
CMC only
No clinical, PK or nonclinical modules. We'd rather cover Module 3 properly than try to cover everything.
Coverage
Where CMCfy is today
CMCfy covers CTD Module 3 and Module 2.3 for small molecules and biologics, including biosimilars and cell and gene therapies, in the US and the EU. It also writes the GMP reports behind the dossier: stability, method validation and transfer, PPQ, cleaning validation, OOS, deviation and CAPA, change control and the annual product review. It drafts the CMC parts of Module 1, IND and IMPD quality sections, DMFs and ASMFs, and classifies post-approval changes under ICH Q12.
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.