AI drafting and QC in Microsoft Word
Local and Country Labels
Adapt the core data sheet or a reference label to one market’s template and approved wording, section by section, in Microsoft Word.
See Local labels 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 local label adapts the core data sheet to one country's rules and approved wording. 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 adapt a core label to local country labelling?
Yes, as a drafting aid for affiliate and regional labelling teams. PharmAssist drafts the local label from the designated source, usually the CCDS or the reference regional label, using the market template and local requirements your team supplies. The pane lists the files used for the draft and displays candidate source passages where it finds a match. Review those passages against the original source. Local requirements that are not covered are flagged.
How this document gets written today
Affiliates and regional teams carry core labelling into dozens of local labels, each with its own template, mandatory statements and timelines. Deviations from the core have to be deliberate and documented.
Most errors come from carrying an outdated sentence forward or missing a local requirement. Checking each label against its designated source is slow work across many markets.
What your team can work on
The agreed market-specific template and the local requirements your team supplies.
Local label drafts
Draft the local label in the market template from the designated source, section by section.
Comparison with the source
For a local label, review each deviation from the core against the designated source and record the reason in your deviation process.
Local requirement flags
Requirements supplied by your team that the draft does not yet cover are listed in the Checks panel.
Consistent wording across markets
Approved local wording can be reused as a source so the same concept reads the same way each time.
How it works for Local labels
Choose the market
Select local labelling and the market template.
Add sources
Upload the CCDS or reference label and the local requirements.
Draft and compare
Draft each section and compare it with the designated source.
Insert and route
Insert into Word and route through affiliate and regional 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.
- CCDS or reference regional label
- Local market template
- Local regulatory requirements supplied by your team
- Previously approved local wording
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
Does it translate labels?
PharmAssist drafts in the language of your template and sources. Translation workflows and certified translation stay with your existing providers unless agreed otherwise during scoping.
How are deviations from the CCDS handled?
A reviewer compares the local draft with the designated source and documents each deviation in your usual deviation process.
Can affiliates use it without central labelling?
Access and review roles are agreed during implementation. Most teams keep central labelling as the approver of the source and affiliates as authors of the local label.
Who reviews and approves the Local labels?
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
Regulatory labelling
US Prescribing Information
Draft PLR-format prescribing information from your CCDS and approved sources.
Read more
Regulatory labelling
EU Summary of Product Characteristics
Draft QRD-structured SmPC sections from your core data sheet.
Read more
Regulatory labelling
EU Package Leaflet
Draft patient leaflet sections in plain language from the approved SmPC.
Read more
Talk to us about Local labels
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