CMC writing tools for pharma teams

Validation and stability reports in minutes. Your data never leaves your computer.

Write the protocol, upload your raw data, fix what doesn't match ICH guidance, and download a review-ready Word report. Every calculation runs in your browser, with nothing uploaded.

Start 14-day free trial Try the tools

Built by CMC scientists. Aligned with ICH Q1E, Q2(R2) and Q14.

STB-2026-014 · Assay · 25 °C / 60% RH0 network requests
30months proposed shelf life
ICH Q1E · common slope, separate intercepts · 3 batches to 18 months
limit 95.0% 30 mo 0 18 36
MajorAccuracy design below ICH Q2(R2)Protocol plans 6 determinations; the guideline expects 9 over 3 levels.
FixedLinearity criterion matched to protocolr ≥ 0.995 applied from MVP-2026-031.
How it works

From protocol to signed report in four steps

Numbers and pass/fail outcomes come from fixed, verifiable calculations. AI only helps with review and wording, and it is never allowed to change a number.

01

Write or upload the protocol

Pick the study type and CMCfy drafts an ICH-aligned protocol, or bring your own as Word or text.

02

Add your raw data

Paste or upload results from Excel or CSV. Calculations run instantly in your browser.

03

Resolve the alerts

CMCfy checks the protocol, data and criteria against the guideline. You fix or justify each gap before reporting.

04

Download the report

A complete Word report with tables, charts, resolved alerts and sign-off lines, ready for QA review.

Tools

Start with the reports you write every week

Each tool includes protocol writing, guideline checks and Word export.

Available

Stability Studio

Shelf-life estimation and stability reports from long-term data.

  • Regression per batch and ANCOVA poolability
  • 95% confidence bound and extrapolation limits
  • Report with chart, tables and conclusion
ICH Q1A(R2) · Q1E
Open Stability Studio
Available

Method Validation Studio

Validation protocols and reports for assay, impurity, dissolution and ID methods.

  • Linearity, accuracy, precision, LOD/LOQ
  • Protocol review against the guideline
  • AI-drafted narrative with number checks
ICH Q2(R2) · Q14 · USP <1225>
Open Method Validation Studio
Available

OOS, Deviation and CAPA

Structured investigations from first lab check to CAPA effectiveness.

  • Phase I and Phase II OOS workflow
  • Root cause analysis and impact on other batches
  • CAPA plan and effectiveness check
21 CFR 211.192 · FDA OOS guidance (2022) · ICH Q10
Open Investigation Studio

On the roadmap: specifications and CoA, batch analysis, nitrosamine and elemental impurity risk assessments, Annual Product Review, and Module 3 drafting for IND and NDA submissions.

Security

Built for teams that can't put data online

CMCfy is designed so your QA and IT teams can check every claim themselves.

Zero network requests

The tools run in your browser under a strict security policy (connect-src 'none'), so the browser itself blocks any attempt to send data out. A live counter shows the count.

Works offline, even air-gapped

Download a single locked file and run it on an isolated PC. Calculations and Word reports work with no internet at all.

AI on your terms

AI review and drafting are optional and run only when you click. Use CMCfy AI under a zero-retention agreement, or connect your company's own cloud AI.

Your documents stay yours

Reports save to your own folders and drives. CMCfy keeps only your login and billing details, never your data.

Version-locked releases

Each release is fixed and documented, so QA can qualify a version and know it won't change underneath them.

Your experts sign

CMCfy drafts; your qualified people review and approve. Every report carries sign-off lines and a review notice.

Pricing

Simple plans, 14 days free

Prices in USD. Annual billing includes two months free.

Solo

$49/ month
  • One tool
  • One user
  • Offline copy
Start trial

Pro

$149/ month
  • All tools
  • One user
  • CMCfy AI review and drafting
Start trial

Team

$399/ month
  • All tools, 5 users
  • Company sign-in (SSO)
  • Shared templates
Start trial

Enterprise

Custom
  • Unlimited users
  • Your own cloud AI
  • Self-hosted or air-gapped
  • Validation support pack
Talk to us
Questions

What QA and IT usually ask

Is CMCfy a validated GxP system?

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.

Does any of our data reach CMCfy servers?

No. Calculations and report generation run in the browser on your computer. The only things CMCfy stores are your account login and subscription. You can confirm this with your browser's network tools or by using the offline copy.

Where does the AI run?

Only where you choose. On Pro and Team plans, CMCfy AI runs under a zero-data-retention agreement. Enterprise customers can connect their own Azure or AWS AI account so text never leaves their cloud. AI never changes calculated numbers or pass/fail outcomes.

Which guidelines do the tools follow?

ICH Q1A(R2) and Q1E for stability; ICH Q2(R2), Q14 and USP <1225> for method validation; 21 CFR 211.192, the FDA OOS guidance and ICH Q10 for investigations. Each report cites the guideline it follows.

Can we use our own report templates?

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