Regulatory AI Workflows

Regulatory work, delivered —
software drafts, experts decide.

Our core service. MedNova runs the analysis and drafts findings with their sources attached; a regulatory or validation expert reviews every one before it reaches you.

Book a regulatory readiness call
Across the lifecycle

Everything we deliver, across the lifecycle.

Regulatory and validation work on one source-linked foundation. Every statement traces back to your documents and to public sources, and an expert reviews it before it reaches you.

Regulatory

  1. Before you file

    IND gap assessmentPrioritized gaps across CMC, nonclinical, and clinical, with predicted reviewer questions labeled as predictions and a recommended action for each gap.

  2. Writing the IND

    IND generationIND sections drafted from your source data, with each statement traceable to where it came from, then reviewed and edited by an expert.

  3. In the clinic

    Clinical summary reportsClinical data summarized from your study documents, with figures and statements traced back to the source tables and listings.

Validation

  1. Before execution

    Protocol generationValidation protocols, such as IQ, OQ, and PQ, drafted from your validation plan and requirements.

  2. After execution

    Report generationValidation reports drafted from your executed results, with each statement traced to the data behind it.

  3. Any time

    Documentation reviewCompleteness, cross-document consistency, and requirement-to-test traceability checks on documents you already have.
Strategy included At every stage, our experts advise on what to do next. It is part of the fee.
Why now

Regulators now review with AI. Sponsors are still filing blind.

“Submissions that are disorganized, that bury key data, or that require reviewers to synthesize inputs may fare poorly when the first pass is algorithmic.”
Steve Silverman, former Director, FDA CDRH Office of Compliance · What the FDA?
“Elsa’s algorithms may detect patterns or anomalies that human reviewers might overlook, leading to new types of information requests or queries that are more data-driven or granular.”
Kimberly Chew, Odette Hauke & Kathleen Snyder, regulatory attorneys and consultants · Clinical Leader

FDA launched Elsa, its agency-wide AI tool, in June 2025; agentic AI followed in December. If an algorithm reads your filing first, have your filing checked before you send it. That is the work we deliver.

Focused services

Go deeper.

High-intent

IND Gap Assessment

Find filing risks before FDA does — a prioritized gap list across CMC, nonclinical, and clinical, with recommended actions.

Learn more → High-intent

Validation Documentation

IQ, OQ, and PQ protocols and reports, with traceability matrices — source-traced, expert-reviewed, audit-ready.

Learn more →
Questions

Before you book.

Is the AI output FDA-ready as delivered?

No. Every statement is source-traced and an expert confirms, edits, or removes it before delivery. Reviewer questions are labeled as predictions. We do not claim to reproduce or approximate FDA’s internal review systems.

What documents do you support?

IND gap assessments and IND generation, clinical summary reports, and validation protocols and reports (IQ, OQ, PQ) — plus documentation review on files you already have.

What are the turnaround times?

Turnaround depends on scope and is confirmed on the readiness call.

Book a regulatory readiness call.

Tell us what you are working on. We will tell you what a scoped engagement would cover and how it would be priced.

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