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AI-Native CMC Documentation

Most regulatory delays trace back to CMC documentation.

BioPrism is a CMC-native AI platform that turns experimental data and manufacturing records into submission-ready regulatory documents. Across the biopharma development lifecycle, BioPrism reduces months of manual compliance work to days.

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Built by CMC practitioners from
  • Merck
  • AstraZeneca
  • Spark Therapeutics
  • Passage Bio

The cost of the status quo

The hidden cost of CMC documentation gaps.

74%

of FDA Complete Response Letters cite manufacturing or quality issues.1

~$1.25M

cost to produce manufacturing sections per submission, per program.2

8.4mo

average time to resolve a single CMC inquiry during FDA review.3

Each one points to the same gap: documentation that isn’t ready when the science is.

  1. 1FDA CRL release via openFDA, July 2025; analysis by Pharma Manufacturing.
  2. 2~5,000 expert hours at $250 per hour.
  3. 3Wills, Drago & Pietrusko. Mol Ther Methods Clin Dev. 2023.

The Platform

Built for CMC, end to end.

Source documents to submission-ready CMC sections. With traceability and review built in.

  1. 01 / Input

    Upload Data

    Experimental data, batch records, analytical results, and manufacturing documentation, ingested in their native formats.

    • Batch records
    • Assay data
    • Specs
  2. 02 / Prism

    BioPrism AI Engine

    CMC-native models structure, draft, and cross-reference every section, with full source traceability and human review checkpoints at every step.

    • Structured authoring
    • Traceability
    • Review gates
    • Audit trail
  3. 03 / Output

    Submission-Ready Documents

    CTD-formatted sections, ready for regulatory submission, every claim linked back to its source record.

    • CTD Module 3
    • IND / BLA
    • Source-linked

Where the time goes

Shift the work from drafting to judgment.

BioPrism shifts expert effort to where it matters. Authoring collapses. Review and judgment do not.

<70%

less time on CMC authoring. Experts focus on review and judgment, not first drafts.

Why now

The industry is shifting. The infrastructure has not caught up.

Biopharma teams face structural changes in how regulatory documentation must be authored, exchanged, and validated. BioPrism is built for what comes next.

  1. Structured authoring is the new baseline

    Emerging regulatory frameworks require structured, machine-readable submissions. Legacy authoring tools cannot meet them.

  2. Pipeline volume is outpacing CMC capacity

    More candidates, the same documentation headcount. CMC has become the gating function for clinical timelines.

  3. AI is finally credible in regulated workflows

    Domain-specific, controlled AI systems can now meet the audit and traceability standards regulators expect.

Who built it

Built by people who have lived the problem.

BioPrism is built by a team of CMC, regulatory, and AI/ML practitioners. The founding team brings 20+ years of regulatory and manufacturing experience across Merck, AstraZeneca, Spark Therapeutics, and Passage Bio, including active authorship of a gene therapy BLA currently under FDA review.

The technical foundation is built by senior engineers with two decades of large-scale engineering leadership at Amazon, Coinbase, Barclays, JPMorgan, NYSE, Thomson Reuters, and the New York Times. Domain depth is reinforced by senior CMC and analytical practitioners and a scientific advisory board with biologics and gene therapy expertise.

Regulatory & ManufacturingTeam experience

  • Merck
  • AstraZeneca
  • Spark Therapeutics
  • Passage Bio

Engineering at ScaleTeam experience

  • Amazon
  • Coinbase
  • Barclays
  • JPMorgan
  • NYSE
  • Thomson Reuters
  • New York Times

Request a Demo

See what regulatory documentation looks like when it is built right.

Write to info@bioprism.ai

For biopharma teams across drug development