Where regulatory data becomes regulatory documents

Author regulatory content from a single source of truth.

CMC, labeling, and clinical protocols—all driven by semantic data models, with AI that works inside your validated structures.

Built for medical writers, regulatory affairs, quality teams, and the data teams that support them.

Regulatory content wasn’t designed for how pharma works today

Copy-paste from LIMS, ERP, spreadsheets

Same data in 20 places—no single truth

Hunt down every document when specs change

Decades of knowledge locked in PDFs

A single source of truth that flows in both directions

Data teams define semantic models. Authors bind content to live data. Documents render automatically—and content flows back to enrich the data.

Data Teams

  • Define semantic models
    Batches, specs, stability, outcomes

  • Build in DataStudio
    Visual model builder, no code

  • Publish for authors
    One source of truth

Authors

  • Bind to data models
    Live data, not copy-paste

  • Smart tables + logic
    Loops, conditionals, controlled terms

  • Write narrative content
    Human expertise + AI assist

Output

  • Render documents
    Word, PDF, eCTD-ready

  • Re-render anytime
    Fresh data, edits preserved

  • Always compliant
    Validated structure built-in

  • AI extracts structured data from content → human review → back to single source of truth

Documents inform data. Data drives documents. Perfect sync, forever.

Bi-directional data flow

Most platforms are one-way: data in, documents out. Zefra is different—your documents enrich your data, creating a living knowledge base.

Data → Documents

Bind to semantic models

Content pulls live data—no copy-paste

Smart tables with logic

Loops, conditionals, controlled terminology (CDISC, NCI)

Re-render with fresh data

Human edits preserved via stable IDs

Documents → Data

Authors write freely

Narrative content, natural authoring flow

AI extracts to model

Structured data from unstructured content—even legacy PDFs

Human review & approve

No black boxes—approved data becomes single source of truth

This is how your documents and data stay in sync—forever.

AI That Works Inside Your Validated Models

Not text generation. Structured intelligence that respects your data models and regulatory constraints.

Co-Editing

AI drafts content, you refine it. Stable IDs ensure your edits survive re-rendering—unless you explicitly regenerate.

Section Generation

Link source documents to any section. AI generates drafts based on your references and data context.

Data Extraction

Author writes free-form narrative. AI extracts structured data to your semantic model. Human reviews before commit.

Rules Validation

Validate against ICH standards or define custom organizational rules. Real-time feedback as you author.

Ready to see data-driven
regulatory authoring?

See how Zefra.ai can transform your regulatory content workflow.