AI drafting and QC in Microsoft Word
REMS Documents
A REMS sets out how a serious risk will be managed, and it has to match the label and the safety data. PharmAssist drafts the components and keeps that link visible.
See REMS drafted in Word
A short demo on a fictitious study and product. In a live demo we walk through the same workflow and answer your questions about sources, review and deployment.
Read the transcript
A REMS document sets out how a serious risk will be managed, and it has to match the label and the safety data. PharmAssist works inside Word. Choose the document type and add your source files. It lays out the document's outline, right in Word. Pick a section, and PharmAssist drafts it from your sources. Review the draft, then insert it into your document. You can also ask questions in chat. Answers come from your own files, and show which ones they used. From your sources to a draft in Word, ready for expert review. Book a demo at gentext.ai/pharma.
Can AI help draft REMS documents?
Yes, as a drafting and consistency aid. PharmAssist drafts REMS components, such as the REMS document, communication materials and assessment report sections, from your approved risk strategy, labelling and safety data. It cites the source for each statement and checks that required elements are covered, so the materials stay consistent with the label.
How this document gets written today
A REMS can include a Medication Guide, a communication plan, elements to assure safe use and an implementation system, with assessments on a set timetable. Every piece has to agree with the approved labelling and with each other.
When the label or the safety position changes, REMS materials have to follow, and checking every component by hand is slow.
What your team can work on
Applicable REMS requirements under section 505-1 of the FD&C Act and your agreed sponsor templates.
REMS component drafts
Draft the REMS document, communication materials and assessment report sections in your templates.
Required-element review
Check that the elements your strategy requires are covered, and list anything missing.
Label consistency
Statements are cited to the label and safety sources, so differences are visible to the reviewer.
Assessment support
Draft assessment report sections from the metrics and data your team supplies.
How it works for REMS
Choose REMS
Select REMS and the component you are drafting.
Add sources
Upload the approved strategy, label, safety data and current materials.
Draft and check
Draft and review citations and required-element checks.
Insert and review
Insert into Word and complete review in your process.
What it drafts from
Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.
- Approved risk strategy and goals
- Current prescribing information and Medication Guide
- Safety data and assessment metrics
- Current approved REMS materials
What stays with your team
PharmAssist supports your document workflow. Interpretation, medical and regulatory judgement, approval and submission stay exactly where they are today, with qualified people and your existing review chain.
Choose GenText-hosted SaaS or a private deployment. Confirm access, data handling, model services and retention during supplier qualification.
Security and deployment detailQuestions we are asked about this document
Which REMS materials can it draft?
Any component your team supplies a template and sources for, typically the REMS document, communication plan materials and assessment report sections.
Does it check REMS materials against the label?
Each statement cites its source, so a reviewer can see where a REMS statement matches or departs from the approved labelling.
Can it help with REMS assessment reports?
Yes. It drafts assessment sections from the metrics and survey results you supply, with each figure cited.
Who reviews and approves the REMS?
Your qualified specialists do. PharmAssist drafts and checks; scientific interpretation, medical and regulatory judgement, quality review and approval stay with your team and your existing review chain. Open questions and missing inputs stay visible in the draft until a person resolves them.
Does PharmAssist work inside Microsoft Word?
Yes. PharmAssist is a Microsoft Word add-in for Windows, Mac and Word on the web. You choose the document type, add your source files, review the outline and section drafts in a side pane, and insert approved text into the document you are already working on.
Where does our data go, and do we need a Veeva connection to begin?
Choose GenText-hosted SaaS or a private deployment. Data handling, model services and retention are confirmed with your technical owner during supplier qualification. A demonstration starts with fictitious documents and upload; connections to Veeva Vault or other source systems are scoped during implementation.
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Draft ICH E2F DSUR sections from your reporting-period safety data.
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Talk to us about REMS
Tell us your role, source material and next document milestone. We will confirm the demonstration scope and define a paid pilot with your team.
Prefer email? alex@gentext.ai