Regulatory Filings,
Drafted to Regulatory Requirements

RegulArk researches the reference drug and drafts each section of your dossier, easing your regulatory team's workload and raising the quality of every filing.

In development. Starting with ANDA dossiers for the US market.

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What We're Building

One platform that prepares complete regulatory dossiers: every section, for every market. Your regulatory team reviews and decides; RegulArk does the research and the drafting.

Dossier drafting

Research and drafting for each section of your dossier, reviewed and approved by your team.

Filing tracking

One view of every filing: where each dossier stands, what is due next, and every response from the agency.

How It Works

  1. Research

    RegulArk reads the reference drug's approved labeling and the current requirements.

  2. Draft

    It drafts each section of your dossier.

  3. Review

    You review changes, not pages. Each change sits beside the reference, with its reason.

  4. Approve and record

    Your reviewer makes the call, as they do today. RegulArk keeps the record: who, when, and on what source.

Where We Start

US generics (ANDA), Module 1 labeling: the draft labeling, the side-by-side comparison with the reference label, and the annotated draft.

Module 1, where we start. Regional administrative information, including the labeling.

Module 2. Summaries of the information in Modules 3 to 5, written to a fixed structure.

Module 3. Quality: the drug substance, the finished product, and how they are made and tested.

Module 4. Nonclinical study reports, where a dossier needs them.

Module 5. Clinical study reports. For a generic, mainly the bioequivalence studies showing it matches the reference drug.

Next: the rest of the dossier (Modules 2 to 5), then dossiers for other markets.

How we handle your data, and how your team validates RegulArk: Security & Validation →

Why It Matters

Less time drafting

Fewer deficiency letters

A clear record of every decision

See It on Your Own Product

We'll walk your regulatory team through a dossier section built from a reference drug you choose.

Request a demo