CMCfy pricing: four plans, each with 14 days free.

The CTD quality sections for drug substance (3.2.S) and drug product (3.2.P), the appendices (3.2.A) and regional information (3.2.R), for small molecules and biologics. The QOS Composer then writes the Quality Overall Summary (Module 2.3) from the same data and lists facts that disagree between sections. CMCfy also writes the GMP reports behind the dossier, such as stability, method validation, PPQ, cleaning validation and the annual product review.

Each section downloads as Word or PDF, and the QOS Composer arranges your files in the eCTD Module 2 and Module 3 folder structure. Your publishing tool still builds the eCTD backbone and validates the sequence, and your qualified people review and approve the content first.

CMCfy is a drafting and calculation aid. Your qualified people review and approve every report, and the final record lives in your own document system. For customers who qualify the tool, we provide release notes, test evidence and a validation support pack.

No. Calculations and report generation run in the browser on your computer. The only things CMCfy stores are your account login and subscription. If you run a CMCfy AI step, the text you approve passes through to the AI provider and is not stored or logged by CMCfy. You can confirm this with your browser's network tools or by using the offline copy.

Only where you choose. On Pro and Team plans, CMCfy AI runs under a zero-data-retention agreement. Enterprise customers can connect their own Anthropic, AWS Bedrock, Azure, Google Vertex, OpenAI or xAI account, so the text goes straight from the browser to their account and CMCfy never sees it. AI can also be switched off. You always see the exact text before it is sent, and AI never changes calculated numbers or pass/fail outcomes.

ICH M4Q(R1) for the CTD structure; ICH Q1A(R2) and Q1E for stability; Q2(R2) and Q14 for methods; Q3A–Q3D, M7, Q6A and Q11 for small molecules; Q5A(R2), Q5B, Q5D, Q5E and Q6B for biologics. For the US, FDA guidance and USP; for the EU, EMA guidelines and Ph. Eur. Each section cites the guideline it follows for the region you pick.

Yes. The tools read Excel, CSV, Word, PDF, OpenDocument and RTF files, and scanned pages or photos through text recognition that also runs on your computer. Scanned text shows a confidence score so you can check it.

Yes, on the Team and Enterprise plans. Company templates control headings, wording and layout, while the calculations stay the same.