Regulatory, Medical and Strategic Writing

We write complex pharmaceutical documents with purpose-built AI.

We produce them up to 6× faster than a traditional consultancy, at a competitive price.

Subject-matter experts shouldn’t be writing and formatting templated documents. We allow their time to be spent on the science instead.

01 Regulatory
02 Clinical Development
03 Strategic Intelligence

Our experts come from

PIERRE FABRE
MERCK
Pfizer
NOVARTIS
Serono

Approach
Our approach

Internal AI software, paired with an expert human in the loop.

Our in-house software handles the drafting, source-tracing and formatting. Senior reviewers who have performed actual submissions use it to generate your documents.

A. Software

Proprietary AI Software

AcribaWord is our own editor. It reads your reports, the relevant guidelines, and any other relevant information. Then it produces a consistent submission-ready document which our reviewers can iterate on.

B. Pharmaceutical Expertise

Expert Review

Our experts work inside AcribaWord to bring the document to submission quality. It runs QC on the reports for them, so their time goes to content and strategy, not formatting.

CASE · 001 Phase 2 biotech · Filed Q1 2026
Case study

30-day IND update for a Phase 2 biotech.

We delivered an IND update in thirty days: fifteen documents, including M2.4, M2.5 and M2.7 summaries written from scratch. The price was far below the nearest quote, which ran three months or more. Every page was reviewed by a former CSO who filed multiple INDs in the past.

Days to delivery 30 Competing quotes: 3+ months.
Documents 15 Nonclinical & clinical summaries included.
Reviewer 1 Former CSO who has filed multiple INDs.
Agency response Approved
without questions
No clock-stopping requests, no minor deficiency letter.
Document set · IB · M2.4 · M2.5 · M2.6 · M2.7 · CSP · CSR · supporting summaries Modality · Small molecule
AcribaWord
Our technology

Claude, ChatGPT or Gemini are not suited for pharmaceutical documents.

Generic AI tools can’t ingest the inputs of a drug program. One program is dozens of reports and hundreds of pages, dense with tables and figures. And they can draft a simple document, but not the formatting and cross-referencing a regulatory or medical dossier requires.

Faster drafting
Section-aware AI suggestions that respect regulatory structure.
Regulatory intelligence
ICH, EMA and FDA guidelines, read in the context of your project.
Source trace
Every sentence linked to its originating protocol, table or safety record.
Connectors
PubMed, ClinicalTrials.gov, FDA, EMA, PMDA and your internal corpus.
Privacy & security
Never used to train AI models. EU-hosted, ISO 27001 compliant, SOC 2 in progress.

Note: AcribaWord is also available as a standalone product. Enquire about licensing →

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Expertise
Network of experts

Every document is signed off by an expert from our network.

We work with experts across most modalities and therapeutic areas. We have a partnership with CXO Swiss, a network of Swiss pharmaceutical leaders across clinical, regulatory, preclinical, CMC and finance.

Get in touch

Tell us about your program. 

Get in touch