Skip to content
Draft a section →
$199 per section

Test Asthra on one section of your real submission.

Bring your own sources, pick one section of a CSR or protocol, and get a draft where every sentence is cited and every gap is flagged. Redraft and edit it as much as you like. $199, once.

Draft a section for $199 →Watch the full recording
  • 0 fabrications in benchmarks
  • Never trained on your documents
  • No subscription, no seats
Full recording

Watch Asthra draft a real section, start to finish.

Nothing sped up and nothing staged. We paused during the longer waits to save you time, and each time we say how many minutes went by. What you see is what your section will get.

Open in Loom ↗

Feature by feature

One feature, one minute.

Short, silent clips of what Asthra does in Word, from adding your sources to checking the last number.

Three steps, nothing to set upPick the document type, add your sources, choose the sections. Drafting starts.
Your sources, read and labelledUpload a folder. Asthra works out what each file is and when it is ready to draft from.
Every line citedHighlight any passage in Word and see the source pages behind it.
It tells you what it couldn’t findGaps are flagged in the draft instead of being filled with a guess.
Calculated, not estimatedDerived numbers and tables are worked out from your sources, with the working shown.
Change any passage by askingSelect text, say what you want, and approve the edit before it goes in.
Every flag in one passAll open issues in one list, by section and severity, resolved with your approval.
Watch each section get checkedEach section is checked against its sources as it is drafted.
A regulator’s read before the reviewerEach section is audited against guidance and precedent, with the evidence quoted.
Redo one section, your wayRedraft a single section with your own instructions. The rest stays as it is.
Start from the draft you already haveBring an existing document and let Asthra build on it.
References straight to EndNoteInsert literature references at the cursor, or export them all as a .ris file.
Pay for the sections you needDraft only the sections you pick, or the whole document.
Every document you write, in one placeClinical, CMC, safety and device documents for FDA, EMA, PMDA and global submissions.
Your own templatesEnterprise teams can have their own templates and SME rules onboarded.
Price and timeline

Draft it in-house with Asthra, or outsource it.

What each submission typically costs to outsource, next to drafting it in-house with Asthra. Asthra writes the cited first draft; your writer reviews and signs off. Not ready for a whole document? Start with one section.

Outsource to an agency or CROIn-house with AsthraStart with
DocumentCostTimelineFull documentTimeline
Clinical
Clinical trial protocol$18k–$63k6–10 weeks$1,99915 days$199one section
Clinical study report (CSR)$30k–$100k8–12 weeks$1,99915 days$199one section
Investigator's brochure$15k–$63k6–10 weeks$79915 days$99one section
Informed consent form, adult$3k–$13k2–4 weeks$24915 days$249whole document
Informed consent and assent, pediatric$6k–$20k3–5 weeks$79915 days$99one section
Bioequivalence study protocol$6k–$20k3–5 weeks$1,99915 days$199one section
Biosimilar comparative study protocol$18k–$55k6–10 weeks$1,99915 days$199one section
IMPD, safety and efficacy section$12k–$40k5–8 weeks$79915 days$99one section
Statistical analysis plan$9k–$38k4–8 weeks$79915 days$99one section
Lay summary of trial results$3k–$13k2–4 weeks$24915 days$249whole document
Safety
Development safety update report (DSUR)$12k–$40k6–8 weeks$79915 days$99one section
PSUR / PBRER$23k–$75k8–10 weeks$1,99915 days$199one section
Risk management plan$15k–$50k6–10 weeks$79915 days$99one section
Regulator meetings
Advisory committee briefing document$60k–$200k12–20 weeks$79915 days$99one section
INTERACT meeting package$6k–$20k3–5 weeks$24915 days$249whole document
Pre-IND meeting package$15k–$50k6–8 weeks$79915 days$99one section
Type A meeting package$6k–$25k2–4 weeks$24915 days$249whole document
End-of-phase meeting package (Type B)$23k–$75k6–10 weeks$24915 days$249whole document
Type C meeting package$15k–$50k6–8 weeks$79915 days$99one section
Type D meeting package$5k–$20k3–4 weeks$24915 days$249whole document
Response to health authority questions$6k–$30k2–4 weeks$79915 days$99one section
Scientific advice briefing document (EMA and national agencies)$15k–$50k6–8 weeks$79915 days$99one section
Meeting request letter$2k–$8k1–2 weeks$24915 days$249whole document
CMC and CTD
CMC Module 3, ANDA$23k–$75k8–12 weeks$1,99915 days$199one section
CMC Module 3, biologic$60k–$200k16–24 weeks$1,99915 days$199one section
CMC Module 3, small molecule$38k–$125k12–16 weeks$1,99915 days$199one section
CTD Module 2 summaries$60k–$200k12–20 weeks$1,99915 days$199one section
CTD Module 5$30k–$125k10–16 weeks$1,99915 days$199one section
IMPD, quality section$15k–$50k6–8 weeks$79915 days$99one section
Labeling and designations
US prescribing information (USPI)$12k–$50k6–10 weeks$79915 days$99one section
EU product information (SmPC, PIL)$12k–$50k6–10 weeks$79915 days$99one section
Paediatric investigation plan (EU)$15k–$63k8–12 weeks$79915 days$99one section
Initial pediatric study plan (US)$9k–$38k6–10 weeks$79915 days$99one section
Orphan drug designation request$9k–$38k4–8 weeks$79915 days$99one section
Medical devices
Clinical evaluation report (EU MDR)$23k–$100k10–16 weeks$79915 days$99one section
Design verification test report$3k–$15k2–4 weeks$24915 days$249whole document
Device PSUR (EU MDR)$9k–$38k6–8 weeks$79915 days$99one section
Technical documentation (EU MDR)$45k–$150k12–20 weeks$1,99915 days$199one section
Q-Submission (pre-submission) package$9k–$38k4–8 weeks$79915 days$99one section
Device risk management file (ISO 14971)$12k–$50k6–10 weeks$79915 days$99one section
Clinical evaluation plan (EU MDR)$3k–$15k2–4 weeks$24915 days$249whole document
PMCF plan (EU MDR)$3k–$15k2–4 weeks$24915 days$249whole document
PMCF evaluation report (EU MDR)$5k–$20k3–5 weeks$24915 days$249whole document

Outsourced figures are estimates, not quotes: typical writing effort for each document at a US agency or CRO rate of $150–$250 an hour, from kickoff to final draft. The Asthra timeline is 15 days from project start for a full document. Prices in US dollars. How we estimate them.

What $199 gets you

One section, done properly.

Your section isn’t a one-shot generation. You keep working the section until it’s one you’d sign off.

Draft a section for $199 →

  • Unlimited redrafts

    Not happy with the section? Redraft it as many times as you like, until it’s right. No extra charge.

  • Unlimited changes

    Highlight anything in the output and ask: fill a gap, check a number, tighten a paragraph. Asthra goes back to your sources and makes a focused, researched edit.

  • Every sentence cited

    Each line links to the source document, section and page it came from. Select any text to see the passage behind it.

  • Gaps flagged, never guessed

    If a fact isn’t in your sources you get a MISSING INFO marker, not a plausible-sounding guess. Likely regulator questions are flagged too.

  • Yours, in Word

    The draft is written into your own Word document. No subscription, no seats, nothing to cancel.

Benchmarks

When Asthra disagreed with the expert, the expert was wrong. 5 out of 5.

We gave Asthra the same source documents as regulatory experts, scored its unedited drafts fact by fact, and checked every difference against the raw data.

  • 0fabrications across three benchmarked submission types
  • 280/280stability values matched to source
  • 97.7%of expert-reference facts covered
What differedExpert referenceAsthraRaw data agrees with
Transcription errorImpurity result, 3 months, long-term0.20.3Asthra
TypoSub-visible particles ≥25 µm, initial, stress condition70Asthra
Missed observationVisible particles, 2 months, stress conditionNone seen1 flocculent particle in 1 of 3 vialsAsthra
Wrong limit typeSurfactant content, shelf-life criterionRelease limit usedShelf-life criterionAsthra
Spec mismatchProtein concentration, acceptance rangeRange not in the source specRange from the source specAsthra

In the CSR benchmark, Asthra also correctly wrote a 90% confidence interval that the reference had mislabelled as 95%.

Internal benchmark runs, October 2026: stability (CTD 3.2.P.8.3), biologic specifications (3.2.P.5.1) and a clinical study report (ICH E3). Drafts unedited; scored against expert-written reference documents. Identifiers withheld.

Get started

Three steps to your first cited section.

  1. 1

    Open Asthra in Word

    One click loads the Asthra add-in into a task pane beside your document.

  2. 2

    Add your sources

    Protocol, SAP, TLFs or quality records go into a private source library.

  3. 3

    Pick a section, pay $199

    Get a cited draft in your document, then redraft and edit it as much as you need.

Available now

Asthra for Microsoft Word

Opens Word with the Asthra add-in ready to load, in a task pane beside your document.

  • Word for Microsoft 365 on Windows and Mac, and Word on the web.
  • $199 per CSR or protocol section. Pay only when you draft.
  • Your IT team may need to approve the add-in first.
Open in Word →

No desktop Word on this device? Install from Microsoft Marketplace or add it to Word on the web.

Before you buy

What counts as a section?

A numbered heading and everything under it. You choose which one, so pick a section you know well enough to judge.

What if the first draft isn’t right?

Redraft it, as many times as you like. Or highlight the part that’s off and tell Asthra what to change; it goes back to your sources and edits just that passage. Both are unlimited on the section you bought.

Will it make things up?

It’s built not to. Asthra writes only from the source library you give it, cites every sentence, and marks anything missing. Our benchmarks found zero fabrications.

What happens to my documents?

We never train on them. Drafting runs through Anthropic and OpenAI under zero-data-retention agreements, and sources stay in your library until you delete them. The data-handling statement is written to be forwarded to your sponsor; the full detail is on Data Security.

Which documents can I start on today?

Every document in the table is self-serve today, at the price shown. You can start on any of them without a call.

Does my IT team need to approve anything?

Possibly. Asthra runs in Word for Microsoft 365 on Windows and Mac, and in Word on the web. Some organisations require an admin to approve new add-ins first; the data-handling statement above answers most of their questions.

Your sources. One section. $199.

Unlimited redrafts and edits included. If Asthra can’t find something, it tells you instead of making it up.

Draft a section for $199 →Prefer to talk first? Book a demo