Pay per document, or by quote.
Two ways to buy Asthra. Writers and small teams pay per document, with no subscription and no seats. Enterprise deployments are scoped and quoted.
For individual writers and small teams
One price per document, no subscription, no seats. Buy a whole document draft or a single section.
- Every section drafted, with provenance on every claim
- Gaps flagged rather than filled. We never invent a number
- Export to Word, or keep working in the add-in or the web app
- Regenerate any section, as many times as it takes
- Works in the browser and inside Microsoft Word, with real-time co-authoring in the web app
For sponsors, CROs and writing groups
Everything in self-serve, plus what a regulated organization needs to roll it out. Priced on your document mix and volume, not per seat.
- Shared source libraries. One library per program or sponsor, with access granted per person and per document.
- Your templates and document types. Custom document types, template mapping and writing-rule tuning to your house style.
- Single sign-on and provisioning. SSO via SAML or OIDC, SCIM provisioning and audit-log export.
- Deployment in your cloud. Managed SaaS, or the Asthra stack in your own AWS, Azure or GCP account with your keys.
- Security review support. SOC 2 Type 2 report, DPA, BAA and a pre-filled security questionnaire.
- A scoped pilot. 30 days on one document type, benchmarked section by section against your current process.
- An SLA. Agreed response times, with the founders on your scoping calls.
One price per document.
You buy a document draft, or a section of one. There is no subscription, no seat and no credit balance to keep track of.
Complex
Trial protocols, clinical study reports, BE protocols, biosimilar protocols, PSURs and PBRERs, ANDA Module 3, biologics Module 3, CMC Module 3, CTD Module 2, CTD Module 5, Phase 1 IND CMC sections, IND nonclinical summaries, MDR technical documentation, 510(k) submissions
Try now →Standard
Investigator's brochures, pediatric consent and assent, IMPD safety and efficacy sections, statistical analysis plans, IND general investigational plans, DSURs, risk management plans, AdCom briefing documents, pre-IND packages, Type C packages, responses to health authority questions, scientific advice briefing documents, IMPD quality sections, US prescribing information, EU product information, EU paediatric investigation plans, US pediatric study plans, orphan designation requests, clinical evaluation reports, device PSURs, Q-Submission packages, device risk management files
Try now →Focused
Adult informed consent forms, lay summaries, INTERACT packages, Type A packages, end-of-phase packages, Type D packages, meeting request letters, IND cover letters, design verification reports, clinical evaluation plans, PMCF plans, PMCF evaluation reports
Try now →A section is a numbered heading and everything under it. A Focused document is cheaper than two sections of a Complex one, which is why it is sold whole. Prices are in US dollars.
More than 40 document types, across nine regulators (FDA, EMA, PMDA, MHRA, Health Canada, TGA, CDSCO, HSA and Swissmedic), are open for self-serve drafting today. Need a document type that isn't listed, or your own template? Book a demo.
Outsourced, or 15 days with Asthra.
What each document typically costs to outsource to a medical writing agency or CRO, and how long it takes, next to the Asthra price.
| Document | Outsourced cost | Outsourced timeline | Asthra price | Asthra timeline |
|---|---|---|---|---|
| Clinical | ||||
| Clinical trial protocol | $18k–$63k | 6–10 weeks | $1,999or $199 a section | 15 days from project start |
| Clinical study report (CSR) | $30k–$100k | 8–12 weeks | $1,999or $199 a section | 15 days from project start |
| Investigator's brochure | $15k–$63k | 6–10 weeks | $799or $99 a section | 15 days from project start |
| Informed consent form, adult | $3k–$13k | 2–4 weeks | $249Whole document only | 15 days from project start |
| Informed consent and assent, pediatric | $6k–$20k | 3–5 weeks | $799or $99 a section | 15 days from project start |
| Bioequivalence study protocol | $6k–$20k | 3–5 weeks | $1,999or $199 a section | 15 days from project start |
| Biosimilar comparative study protocol | $18k–$55k | 6–10 weeks | $1,999or $199 a section | 15 days from project start |
| IMPD, safety and efficacy section | $12k–$40k | 5–8 weeks | $799or $99 a section | 15 days from project start |
| Statistical analysis plan | $9k–$38k | 4–8 weeks | $799or $99 a section | 15 days from project start |
| Lay summary of trial results | $3k–$13k | 2–4 weeks | $249Whole document only | 15 days from project start |
| IND introductory statement and general investigational plan | $3k–$15k | 2–4 weeks | $799or $99 a section | 15 days from project start |
| Safety | ||||
| Development safety update report (DSUR) | $12k–$40k | 6–8 weeks | $799or $99 a section | 15 days from project start |
| PSUR / PBRER | $23k–$75k | 8–10 weeks | $1,999or $199 a section | 15 days from project start |
| Risk management plan | $15k–$50k | 6–10 weeks | $799or $99 a section | 15 days from project start |
| Regulator meetings | ||||
| Advisory committee briefing document | $60k–$200k | 12–20 weeks | $799or $99 a section | 15 days from project start |
| INTERACT meeting package | $6k–$20k | 3–5 weeks | $249Whole document only | 15 days from project start |
| Pre-IND meeting package | $15k–$50k | 6–8 weeks | $799or $99 a section | 15 days from project start |
| Type A meeting package | $6k–$25k | 2–4 weeks | $249Whole document only | 15 days from project start |
| End-of-phase meeting package (Type B) | $23k–$75k | 6–10 weeks | $249Whole document only | 15 days from project start |
| Type C meeting package | $15k–$50k | 6–8 weeks | $799or $99 a section | 15 days from project start |
| Type D meeting package | $5k–$20k | 3–4 weeks | $249Whole document only | 15 days from project start |
| Response to health authority questions | $6k–$30k | 2–4 weeks | $799or $99 a section | 15 days from project start |
| Scientific advice briefing document (EMA and national agencies) | $15k–$50k | 6–8 weeks | $799or $99 a section | 15 days from project start |
| Meeting request letter | $2k–$8k | 1–2 weeks | $249Whole document only | 15 days from project start |
| IND cover letter | $750–$4k | 1–2 weeks | $249Whole document only | 15 days from project start |
| CMC and CTD | ||||
| CMC Module 3, ANDA | $23k–$75k | 8–12 weeks | $1,999or $199 a section | 15 days from project start |
| CMC Module 3, biologic | $60k–$200k | 16–24 weeks | $1,999or $199 a section | 15 days from project start |
| CMC Module 3, small molecule | $38k–$125k | 12–16 weeks | $1,999or $199 a section | 15 days from project start |
| CTD Module 2 summaries | $60k–$200k | 12–20 weeks | $1,999or $199 a section | 15 days from project start |
| CTD Module 5 | $30k–$125k | 10–16 weeks | $1,999or $199 a section | 15 days from project start |
| IMPD, quality section | $15k–$50k | 6–8 weeks | $799or $99 a section | 15 days from project start |
| IND CMC information (Phase 1) | $15k–$63k | 6–10 weeks | $1,999or $199 a section | 15 days from project start |
| IND nonclinical summaries (2.4 and 2.6) | $15k–$63k | 6–10 weeks | $1,999or $199 a section | 15 days from project start |
| Labeling and designations | ||||
| US prescribing information (USPI) | $12k–$50k | 6–10 weeks | $799or $99 a section | 15 days from project start |
| EU product information (SmPC, PIL) | $12k–$50k | 6–10 weeks | $799or $99 a section | 15 days from project start |
| Paediatric investigation plan (EU) | $15k–$63k | 8–12 weeks | $799or $99 a section | 15 days from project start |
| Initial pediatric study plan (US) | $9k–$38k | 6–10 weeks | $799or $99 a section | 15 days from project start |
| Orphan drug designation request | $9k–$38k | 4–8 weeks | $799or $99 a section | 15 days from project start |
| Medical devices | ||||
| Clinical evaluation report (EU MDR) | $23k–$100k | 10–16 weeks | $799or $99 a section | 15 days from project start |
| Design verification test report | $3k–$15k | 2–4 weeks | $249Whole document only | 15 days from project start |
| Device PSUR (EU MDR) | $9k–$38k | 6–8 weeks | $799or $99 a section | 15 days from project start |
| Technical documentation (EU MDR) | $45k–$150k | 12–20 weeks | $1,999or $199 a section | 15 days from project start |
| Q-Submission (pre-submission) package | $9k–$38k | 4–8 weeks | $799or $99 a section | 15 days from project start |
| Device risk management file (ISO 14971) | $12k–$50k | 6–10 weeks | $799or $99 a section | 15 days from project start |
| Clinical evaluation plan (EU MDR) | $3k–$15k | 2–4 weeks | $249Whole document only | 15 days from project start |
| PMCF plan (EU MDR) | $3k–$15k | 2–4 weeks | $249Whole document only | 15 days from project start |
| PMCF evaluation report (EU MDR) | $5k–$20k | 3–5 weeks | $249Whole document only | 15 days from project start |
| 510(k) premarket notification (eSTAR) | $23k–$100k | 8–16 weeks | $1,999or $199 a section | 15 days from project start |
Outsourced costs are estimates, not quotes. Few vendors publish per-document prices, so each range is the typical writing effort for that document multiplied by a US agency or CRO rate of $150 to $250 an hour. The EMWA 2023 freelance survey puts the median freelance rate at about €82 an hour, and agencies typically charge well above freelance rates. Outsourced timelines run from kickoff to a final draft. The Asthra timeline is 15 days from project start, for every document type.
What people ask before they buy.
How much does a clinical study report first draft cost with Asthra?
A clinical study report (CSR) first draft is $1,999 for the whole document, or $199 for a single section, delivered within 15 days of project start. Trial protocols are priced the same way.
How does that compare with outsourcing the document?
Outsourcing a CSR to a medical writing agency or CRO typically costs $30k–$100k and takes 8–12 weeks. With Asthra the same document is $1,999 and is delivered within 15 days of project start. The table above gives the comparison for every document type, and how the outsourced ranges are estimated.
Is there a subscription or a per-seat fee?
No. Asthra has one price per document. You buy a document draft, or a section of one. There is no subscription, no seat and no credit balance to keep track of.
What counts as a section?
A section is a numbered heading and everything under it. A Focused document is cheaper than two sections of a Complex one, which is why it is sold whole.
What if the draft of a section is not good enough?
Regenerate it. Once you have bought a document or a section, you can regenerate that section as many times as it takes at no extra cost.
Are my documents used to train a model?
No. Your documents are used to draft your document and for nothing else. Drafting runs through Anthropic and OpenAI under zero-data-retention agreements: nothing is stored after the response, and nothing is used for training.
Do these prices apply to enterprise deployments?
No. The per-document prices are for the self-serve product: one writer or a small team buying one document at a time. Enterprise deployments add shared libraries, custom templates and document types, single sign-on, deployment in your own cloud, security review support, a scoped pilot and an SLA. They are quoted after a scoping call, based on document mix and volume.
Try it on a sample study. Then decide.
Open a sample study and see how a section is drafted and cited before you upload a file of your own.