Your IND, drafted section by section from the reports you already have.
Asthra drafts the parts of an Investigational New Drug application that take the most writing: the cover letter, the general investigational plan, Phase 1 CMC, and the nonclinical summaries. Every sentence is cited to your own study reports and data, so your regulatory lead reviews evidence, not prose from nowhere.
What Asthra reads.
The documents your team has already produced on the way to first-in-human. No new system of record.
Nonclinical study reports
Pharmacology, pharmacokinetics and toxicology reports, including GLP studies. These feed the 2.4 overview and 2.6 summaries.
Phase 1 CMC data
Batch analyses, specifications, stability data and the manufacturing summary for drug substance and drug product.
Protocol or synopsis
Design, population, dose and endpoints. Asthra keeps the general investigational plan consistent with it.
Investigator's Brochure
Prior human experience and the reference safety information carried into the plan and cover letter.
Pre-IND meeting minutes
FDA's written responses, so the IND shows how each piece of advice was addressed.
FDA guidance
The applicable guidances for your modality and phase, cited where the draft relies on them.
From study reports
to a reviewable IND draft.
Load what you have
Drop in the reports and data. Asthra sorts them by IND section and lists what is missing before it drafts anything.
Confirm the plan
Asthra proposes which source supports each section. Your team swaps in newer reports or excludes superseded data.
Draft each section
The cover letter, general investigational plan, Phase 1 CMC and nonclinical summaries are drafted into your template, with tables built from the source data.
Review and refine
Your regulatory, CMC and nonclinical leads review in Word or the web app, chat with Asthra to fix a section, and approve each tracked change.
Hand off for publishing
Final sections go to your publishing team or vendor as normal Word documents, with the citations and QC report attached.
Where IND time goes, and where it comes back.
Writing the IND by hand
- −Months of writing between the last GLP report and filing
- −Nonclinical summaries retyped from dozens of study reports
- −CMC, nonclinical and clinical sections drift out of step
- −Pre-IND advice tracked in someone's notes
- −Review starts only once a full draft exists
Drafting the IND with Asthra
- +First drafts of each section in days, not months
- +Summary tables built from the study reports, with citations
- +One source set keeps every section consistent
- +Each pre-IND response linked to where it is addressed
- +Reviewers start as soon as a section is ready
Going in for a pre-IND meeting first? See briefing document automation and our guide on how to write an FDA meeting package.
Common questions on AI-assisted IND writing.
What is AI IND authoring software?+
AI IND authoring software drafts the written sections of an Investigational New Drug application from the documents a sponsor already has: nonclinical study reports, manufacturing and analytical data, the protocol and the Investigator's Brochure. Asthra writes each section to the content FDA expects under 21 CFR 312.23 and cites every statement back to the source document it came from.
Which parts of an IND does Asthra draft today?+
The IND cover letter, the introductory statement and general investigational plan, Phase 1 chemistry, manufacturing and controls information, the nonclinical overview and written and tabulated summaries (CTD 2.4 and 2.6), the clinical protocol, the Investigator's Brochure, and the pre-IND meeting package. Assembly of the complete IND into one submission-ready package is coming soon.
Does Asthra fill in FDA Form 1571 or 1572?+
No. The forms are short and administrative, and your regulatory lead completes them. Asthra drafts the written sections where most of the time goes.
What inputs does Asthra need?+
Final or draft nonclinical study reports, the drug substance and drug product information you have for Phase 1 (batch analyses, specifications, stability, manufacturing summary), the protocol or synopsis, the Investigator's Brochure, and the pre-IND meeting minutes if you have them. Missing information is flagged as a gap rather than filled in.
Is this only for US INDs?+
The IND document types are written for FDA. For EU clinical trial applications, the same sources feed the IMPD quality and safety-and-efficacy sections and the CTA cover letter, which are separate document types in Asthra.
How much does it cost?+
Asthra is priced per document, not per user. The prices for each IND section are listed on this page and on the pricing page, and you can start with a single section.
From the blog
- The Study Report Is in the Data Room, but Could FDA Verify the Study?
FDA said in September that it is adding foreign inspections, including more phase 1 and early-stage trials, and looking harder at foreign studies not run under an IND. For a biotech acquiring an overseas asset, or a CRO adapting an inherited study report, the question moves into diligence: where are the records behind the report, and could FDA inspect them?
- The Expedited IND Pilot Splits the IND into Pieces, and the Writing Plan Has to Follow
FDA's Expedited IND pilot lets a sponsor and a qualified research institution send IND components for review one at a time before the formal IND. Each component has to stand on its own, and whatever FDA says about the first one has to be carried through the rest. For small biotechs and CROs considering an application before 30 October, that is a staffing and contracting question as much as a scientific one.
- Brenus Pharma's STC-1010 IND Acceptance: Multi-Region First-In-Class Writing Before the Guidance Exists
FDA accepted Brenus Pharma's IND for STC-1010 — a first-in-class allogeneic in vivo immunotherapy built on Stimulated Ghost Cells technology — for MSS metastatic colorectal cancer. The program already holds ANSM and AFMPS authorisations in Europe. Multi-region, novel-modality, pre-guidance writing is its own architecture problem.
- Biotech's New Company Model: Chinese Assets and the IND-Bridging Problem
Endpoints identified 18 US biotechs since 2025 launching with in-licensed Chinese clinical-stage assets. The startup model is new. The regulatory writing problem — bridging Chinese trial documentation into a US IND — is not.
What it costs, and how long it takes.
IND cover letter
IND introductory statement and general investigational plan
IND CMC information (Phase 1)
IND nonclinical summaries (2.4 and 2.6)
Pre-IND meeting package
Outsourced figures are typical industry ranges, not quotes. How we estimate them.
Draft one IND
section first.
Start with the section that is holding you up. Load the reports, get a cited draft, and judge it on your own documents.