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Life Sciences & Biotech

Dossiers drafted
from your data.

Regulatory and grant writing is assembly before it is prose: the same facts, restated consistently across hundreds of pages. That assembly is what a model can carry, under a writer who owns the result.

Last reviewed 30 October 2026 · Engineering guidance, not legal or regulatory advice.
All Life Sciences & Biotech →
Pixel illustration for Regulatory & Grant Dossiers: a small printing press producing a family of different page layouts.

What it is

Medical writing AI for regulatory dossiers drafts sections of a submission, such as CTD Module 2 summaries, investigator’s brochure updates or a scientific advice briefing document, from your own study reports and data, with every statement linked to the source table or report it came from. A regulatory or medical writer edits, verifies and signs; the system shortens the assembly, not the accountability.

The same machinery serves non-dilutive funding. EIC Accelerator, Horizon Europe and NIH SBIR applications reuse the science of your dossier in a different shape, and keeping the two consistent is where small biotechs lose weeks.

What it handles

01

Source-linked drafts

Sections drafted only from documents you supply, following the ICH M4 CTD structure or the funder’s template, with each sentence linked to its table, figure or report.
02

Consistency checks

The same dose, population or endpoint stated differently in two modules is flagged, as are numbers that do not match their source tables.
03

Funding applications

Grant sections built from the dossier’s science, with funder rules on page limits and structure checked. Applicants remain responsible for what they submit, and several funders publish their own rules on AI use.
04

Not: regulatory strategy

The system does not decide what to claim, which pathway to take or how to answer an agency question. Those are regulatory judgements, made and signed by your people.

How a section is drafted

DRAFTING PATH
  1. 01
    Source set

    study reports, tables, prior submissions

  2. 02
    Template

    CTD section or funder structure

  3. 03
    Draft with links

    every statement tied to a source

  4. 04
    Consistency check

    across modules and against tables

  5. 05
    Writer review

    edit, verify, sign

  6. 06 · Branch / escalation
    Unsupported claim

    flagged, never filled in

Solid: the drafting pathDashed: gaps returned to the writer
Where the sources do not support a statement the template expects, the draft says so instead of writing something plausible.
Questions

Questions about Regulatory & Grant Dossiers.

Can AI write regulatory submissions?

It can draft parts of them from your source documents and check them for consistency, which is a large share of the effort. It should not author the submission. Agencies hold the sponsor responsible for every statement, so a qualified writer verifies each sentence against its source and signs off. We design the system so that verification is fast, not so it can be skipped.

What are the best AI tools for medical writing?

General writing assistants help with style but cannot see your study data and should not receive it. For dossier work, what matters is drafting only from your controlled source set, citation to the table level, and deployment where confidential data stays on your infrastructure. That is a system built around your documents rather than a tool you paste into.

Can we use AI for grant writing in biotech?

Usually yes, within the funder’s rules. Several major funders have published positions on generative AI in applications, and the applicant stays responsible for originality and accuracy. We keep drafts grounded in your own data and prior text, so the science is yours and the system handles structure, limits and consistency.

Shipped & in build

Real work. Check it yourself.

What we built, what stage it is at, and a link to the live thing wherever there is one.

The updated yourOS homepage: Roxy’s open ring surrounded by bento cards for calls, voice, translation, building, design, apps and more.
The yourOS homepage on a phone, with its compact navigation, welcome film button and bento cards.
youros.tech — the homepage bento hero
Our own · coming soon

yourOS

yourOS is an operating system with an AI at its heart. You talk to it like a person, out loud or typed. It makes your calls, plans your days and works on your projects with a crew of agents, on your own private server. Our own product, built from the first commit; the waitlist is open.

What we built
  • Operating system
  • Roxy
  • Agent crew
  • Voice calls
  • App store
  • Website
Meet yourOS →
The Sonora homepage on desktop: a full-bleed dune landscape behind the headline “Transform Your Life with Sound”, with App Store and Google Play download buttons.
The Sonora homepage on a mobile viewport, showing the same hero reflowed to a single column.
sonora.com — homepage, 1440×900
Live · iOS · Android

Sonora

Website, backend and app assets for Sonora, a free AI sound-therapy app on iOS and Android published by Cognitive AI.

What we built
  • Website
  • Backend
  • App assets
Read the case study →
The updated Podswap homepage on desktop: “Grow on Instagram and TikTok for free, with real engagement from creators your size”, beside a tilted wall of exchange, tool and guide cards on a violet gradient.
The updated Podswap homepage on a phone, with its floating navigation, Instagram and TikTok engagement headline and tilted tool cards.
podswap.app — homepage, 1440×900
Five platforms

Podswap

Brand, website, prototype, apps on five platforms, the AI backend and the algorithm-intelligence pipeline for Podswap, a social growth engine that runs without a human in the loop.

What we built
  • Brand
  • Website
  • Prototype
  • Apps on five platforms
  • AI backend
  • Algorithm pipeline
Read the case study →
The unOpen.AI homepage introducing Roxy, a private AI assistant that remembers who you are.
The unOpen.AI homepage on a mobile viewport.
unopen.ai — homepage, 1440×900
Prototype · closed beta

unOpen.AI

In closed beta: Roxy, a private AI assistant with permanent memory running on infrastructure the user owns. Brand, site, product, backend and conversational design.

What we built
  • Brand
  • Site
  • Product
  • Backend
  • Conversational design
Read the case study →
coherence.com on desktop, headed "Intelligence that moves in phase with people".
coherence.com on a mobile viewport, reflowed to a single column.
coherence.com — homepage, 1440×900
Live

Coherence

Live at coherence.com: brand identity generated with AI agents we directed, the motion system and website for the group behind Sonora, AboutAI, WakeUp and MudShadows. Agent work remains in build.

What we built
  • Brand identity
  • Motion system
  • Live website
  • Agent work — in build
Read the case study →
The new Domain Booth homepage on desktop: the headline “Premium Domains. Serious Buyers. Proven Results.” beside the animated DB monogram.
The new Domain Booth homepage on a phone, reflowed to a single column.
Our build of the Domain Booth homepage — 1440×900
Live

Domain Booth

Live at domainbooth.com for DomainBooth, a premium domain brokerage: a new animated mark, every page redesigned and rebuilt with designed mobile layouts, and a custom CMS for its sales record, featured names, press and enquiries.

What we built
  • Animated mark
  • Every page redesigned
  • Designed mobile layouts
  • Custom CMS
Read the case study →
Who we have built for

Twenty-one years. Names you know.

See all of our work →
  • BBC Good Food logo
  • Charities Aid Foundation logo
  • GAME logo
  • NatWest logo
  • Next logo
  • NSPCC logo
  • Tesco logo
  • Worldpay logo
  • Samsung logo
  • Sony logo
  • Land Rover logo
  • UAP Limited logo
  • Netflix logo
  • Amazon Prime Video logo
  • Mercedes-Benz dealerships logo
  • San Miguel logo
  • Biovene Barcelona logo
  • Seventy7 logo
  • Littlewoods logo
  • Smile logo
  • The Co-operative Bank logo
Let’s talk

Assemble fast.
Sign carefully.

Start with one module or one application and the source documents behind it.

30-minute technical call · no deck