GenText Private Edition
AI that drafts your regulatory documents, inside Microsoft Word
Labelling, safety, clinical and CMC documents are mandatory, rigidly structured, and still assembled by hand over weeks. GenText drafts them from your own approved sources, inside your own cloud. Your experts review and approve.
In production today
Deployed and in daily use at a NASDAQ-listed pharmaceutical company.
Inside your own cloud
Single tenant in your AWS account, your SSO, your own model keys.
Cleared enterprise review
Passed security review and supplier qualification before first deployment.
Built for the teams who own the documents
Medical Writing
Cut the assembly time out of every document so writers spend their hours on judgement instead of formatting and reconciliation.
Regulatory Affairs
Keep labelling consistent across markets, with a traceable line from every statement back to the approved source.
Pharmacovigilance
Turn safety data into structured periodic reports without rebuilding the same document skeleton each cycle.
Medical Information
Answer enquiries from approved labelling at speed, with consistent language across every response.
The documents we draft
GenText covers the regulated authoring estate, from labelling through safety, clinical and CMC. Most customers start with one high pain document family and widen from there.
Labelling
US Prescribing Information
Draft and update the USPI from your company core data sheet, with every change traced back to the source that justified it.
How GenText drafts it
EU SmPC
Generate and maintain the Summary of Product Characteristics in QRD structure, aligned to the core data sheet and to national variants.
How GenText drafts it
Local country labels
Propagate a single core change into every affected country label instead of reconciling each market by hand.
How GenText drafts it
Safety and pharmacovigilance
Clinical
Informed consent forms
Produce site-ready informed consent forms from the protocol and approved safety language, so consent stops gating enrolment.
How GenText drafts it
Clinical study reports
Draft clinical study reports and their synopses from study data, tables and the protocol, in ICH E3 structure.
How GenText drafts it
Biostatistics and nonclinical
Draft statistical and nonclinical sections from source outputs, keeping every number tied to the table it came from.
How GenText drafts it
CMC and communications
CMC and Quality (Module 3)
Draft chemistry, manufacturing and controls sections from your development and manufacturing documentation.
How GenText drafts it
Medical Information responses
Generate standard response documents and letters grounded strictly in approved labelling and the evidence base.
How GenText drafts it
Scientific communications and RWE
Draft publications, congress materials and real world evidence summaries from your own data and approved sources.
How GenText drafts it
How it works
The AI drafts. Your experts approve. Nothing about your review and sign off process has to change.
Connect your approved sources
Company core data sheets, approved labels, study data, style guides and templates stay inside your own cloud. Nothing leaves your environment.
GenText drafts in Word
A complete first draft appears in Microsoft Word, already structured to the required regulatory format and traceable back to the source it came from.
Your experts review and approve
Your writers edit, approve and file through the process you already use. Every regulatory decision stays with a qualified human.
Why a general purpose AI cannot do this work
Regulated authoring demands source traceability, auditability and a validated process. A general chat tool has no line back to your approved sources, no control over what it grounds an answer in, and no fit with the review chain your teams are audited against. GenText is built for that constraint rather than around it, and it runs inside Word where your writers already work, so there is no new system to adopt and no retraining programme.
Architecture and security
Deployment
A Word add-in built on the Office JavaScript APIs, with a single tenant backend deployed in your own AWS account. Your corporate SSO for identity, your own model keys for inference.
Data
Nothing leaves your environment. Your documents are never used to train models, and every draft is traceable to the governed sources and templates you designate.
Controls
Writers review, edit and approve. No regulatory decision is made by AI alone, and your existing approval chain is unchanged.
Integration
We draft from your governed sources and file back, integrating with the vault and RIM platforms you already run rather than replacing them.
Talk to us
Tell us which document family costs your team the most time. We will show you GenText drafting that document, and scope a pilot against your own source material.
Prefer email? alex@gentext.ai