AI regulatory submission software compared, by job

A submission has three jobs. Someone writes the documents. Someone assembles them into an eCTD sequence and sends it. After filing, someone answers the agency's questions. Software marketed as AI for regulatory submissions usually does one or two of these, and the label hides which.

FDA requires NDAs, BLAs, ANDAs and commercial INDs in eCTD format, since May 5, 2017 and May 5, 2018 under section 745A(a) of the FD&C Act. That rule shapes the market. Publishing tools exist because the format is mandatory. AI authoring tools sit upstream of them and hand off content.

This page compares six products by job, using what each vendor says on its own site in November 2026.

The three jobs

What each vendor says

Weave Bio has two products, Submission Builder and HAQ Manager. Submission Builder drafts across Modules 1, 2, 3 and 5 and exports DOCX, and Weave says submission to health authorities stays in the customer's publishing process. HAQ Manager takes in question files, matches similar past questions and drafts source-linked answers. Weave reports that about 70% of in-platform responses at Takeda were AI-drafted, and it says it has completed 12 FDA submissions.

Peer AI describes a unified platform that authors documents, tracks every deliverable in a Command Center and predicts the queries a regulator is likely to raise. It says its authoring drafts CSRs, protocols and INDs 55 to 94% faster.

Bluenote says its agentic platform covers protocols, statistical analysis plans, clinical study reports, eCTD modules and CMC documentation, with SOC 2 Type II and an on-premise option.

Certara (alternatives) sells CoAuthor, which works inside Microsoft Word with more than 275 eCTD templates, and GlobalSubmit, an eCTD tool that publishes, validates and reviews sequences, with live validation for more than 200 error conditions.

Veeva sells Submissions Publishing inside Vault RIM, which publishes directly to the FDA Electronic Submissions Gateway and the EMA gateway and validates sequences against health authority criteria as you build. Veeva says its first Falcon agents for regulatory are planned for November 2026, with agentic authoring later.

How Arca handles each job

Authoring. Arca has dossier outlines for CMC Module 3, IND and NDA/BLA, with built-in AOPs for drafting Module 2 summaries and the Quality Overall Summary, clinical and nonclinical documents, and Module 3. It drafts from your own documents in Veeva Vault, SharePoint, Google Drive, OneDrive or Box. Each statement links to the document and page it came from. A subsection with no source becomes a placeholder, never an invented value. Arca for Word puts the draft in your template with tracked changes.

Assembly. Arca imports an eCTD archive as a product's dossier, with replaced and withdrawn files kept as history. Its eCTD readiness AOP maps your document set to eCTD modules and checks completeness against the deadline. A separate submission QC AOP reconciles numbers, cross-references and consistency before the package ships. The sequence then goes to the publishing tool you already use, so the Vault or GlobalSubmit step is unchanged.

Agency questions. The information request and deficiency response AOP triages an FDA information request, an EMA list of questions or a complete response letter, drafts the answers the record supports and flags the items that need new data. It checks current FDA guidance while it drafts, and a regulatory lead keeps the strategy and final wording. See FDA information requests.

Arca also researches precedent and guidance across FDA, EMA and ICH sources, so the same platform that drafts an answer can show how the agency treated a similar question.

What to check in any submission tool

• Where the record lives. After approval, which system holds the final document and its audit trail?
• Source traceability. Can a reviewer click from a sentence to the page behind it?
• Missing data. Does the draft flag a gap or fill it?
• Handoff. How does content reach your publishing tool, and does it keep your structure?
• Agency questions. Can it handle a letter with dozens of questions, and does it reuse answers you already gave?
• Evidence. Is there a published test you can inspect? Arca's is LifeSci Diamond, 55 regulatory affairs tasks with the harness and ten examples public.

Choosing

Choose Weave if your work is a single dossier and its agency questions on one platform. Choose Veeva Submissions Publishing or GlobalSubmit for the publishing step. Choose Peer AI if program tracking and query prediction are the priority. Choose CoAuthor if your writers want to stay in Word with a template library.

Choose Arca if the same team also does CMC, quality and clinical work and you want authoring, readiness checks, agency responses and research in one place, on top of the Veeva or SharePoint setup you already run. For the CMC side, see AI for CMC Module 3 authoring. For the wider market, see AI software for regulatory affairs and Weave Bio alternatives.

Frequently asked questions

What is the best AI software for regulatory submissions?

It depends on the job. Authoring tools such as Arca, Weave Bio, Peer AI and Bluenote draft the content. Publishing tools such as Veeva Submissions Publishing and Certara GlobalSubmit assemble and send the eCTD sequence. Agency question tools draft responses to information requests.

Can AI prepare an IND, NDA or BLA?

AI can draft sections from your source documents, and a person reviews and approves them. Arca has dossier outlines for IND and NDA/BLA and drafts with a citation behind each statement.

Does Arca publish eCTD sequences?

Arca checks that a document set maps to eCTD modules and is ready, then hands the content to your publishing tool. It also imports an eCTD archive as a dossier.

Can AI answer FDA information requests?

Yes. Arca's information request AOP triages each request, drafts answers from the record, flags what needs data and checks current FDA guidance. Your regulatory lead decides the response.