AI drafting and QC in Microsoft Word
EU Summary of Product Characteristics
Turn your company core data sheet into Summary of Product Characteristics text, section by section, in Microsoft Word, with the QRD structure, citations to the CCDS and checks for required subsections.
See EU SmPC 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
An SmPC turns your company core data sheet into the approved product information, section by section. 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 draft an EU SmPC from a CCDS?
Yes, as a sourced first draft. PharmAssist maps each SmPC section to the matching section of your core data sheet, for example 4.2 Posology from the CCDS dosing section, drafts it in the QRD structure, and cites the source for every statement. Completeness checks show which required subheadings are covered. Your regulatory team reviews and approves the result.
How this document gets written today
The SmPC is the reference for every downstream EU document: the package leaflet, local translations and promotional review all depend on it. A CCDS change has to be carried into the right SmPC sections with QRD headings and standard statements intact.
Regulatory writers spend much of their time mapping CCDS content to SmPC sections, checking posology tables, renal and hepatic adjustments and interaction statements line by line, and confirming nothing required has been dropped.
What your team can work on
Structure follows the EMA QRD product information template and the European Commission SmPC guideline, with your sponsor conventions.
QRD-structured section drafts
Draft clinical particulars such as 4.2 Posology and method of administration, 4.4 Special warnings and 4.8 Undesirable effects in the QRD order, with your template headings.
Section mapping from the CCDS
Each SmPC section draws from the CCDS section that should feed it, so posology comes from dosing, not from a summary elsewhere in the file.
Required-subsection completeness
The Checks panel reports how many required subsections are present, for example special populations under 4.2, before the draft goes to review.
Ready for the package leaflet
Approved SmPC text becomes the source for the patient leaflet, so the two stay aligned.
How it works for EU SmPC
Choose SmPC
Select EU Summary of Product Characteristics and the sections you are updating.
Add the CCDS
Upload the core data sheet and current SmPC. PharmAssist maps SmPC sections to the CCDS sections they draw from.
Draft and check
Draft a section, read the citations, and use the Checks panel for completeness and unsupported numbers.
Insert into Word
Insert the reviewed text into your SmPC document and continue through your normal review.
What it drafts from
Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.
- Company Core Data Sheet (CCDS)
- Current SmPC
- Approved safety and clinical sources
- QRD template version used by your team
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 SmPC sections can PharmAssist draft?
Any section your team supplies sources for, most often 4.1 to 4.9 and 5.1 to 5.3. In the demo it drafts 4.2 Posology and method of administration from the CCDS dosing section.
Does it use the QRD template headings?
Yes. Drafts use the QRD section numbering and the template your team provides, including standard statements where the template requires them.
Can it draft the package leaflet from the SmPC?
Yes. The EU package leaflet workflow uses the approved SmPC as its source and translates it into patient language. See the package leaflet page.
Who reviews and approves the EU SmPC?
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.
Teams that start here often widen to
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EU Package Leaflet
Draft patient leaflet sections in plain language from the approved SmPC.
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US Prescribing Information
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Local and Country Labels
Adapt core labelling to one country’s rules and approved wording.
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Talk to us about EU SmPC
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