AI document assembly for regulated work
Your experts should review regulatory documents, not compile them.
AriaFlow is an AI document assembly platform. It turns your approved sources and existing templates into structured drafts for expert review. Every statement points to its evidence, and missing or conflicting information is flagged, never filled in. Your experts keep interpretation, review and approval.
Built together with the regulatory experts at G&L Scientific and Entourage.
V&V Summary · 4.2 Biocompatibility testing
Cytotoxicity testing per ISO 10993-5 showed no cytotoxic potential for the final device SRC-02 · Test report TR-118, p.4. Sensitisation testing per ISO 10993-10 was negative SRC-03 · Test report TR-121, p.2.
The patient-contact duration is stated as <24 h in the design input SRC-01 · DI-07 and as <30 days in the risk file. Review required Conflict: confirm contact duration
Irritation test results: [MISSING] not in source set
Illustration with synthetic data.
How it works
A controlled path from evidence to document.
Specialised AI agents take over the assembly work in a defined sequence. Your experts step in where judgment is needed, and every decision is recorded.
- 01
Approved sources
Uploaded files and connected systems
Your team - 02
Your template
Existing structure and format, ingested as a workflow
AriaFlow - 03
Specialised agents
Evidence gathering, drafting, citation, checks, formatting
AriaFlow - 04
Review-ready draft
In Word, with sources, gaps and conflicts marked
AriaFlow - 05
Expert review
Interpretation and edits where judgment is needed
Your experts - 06
Decision
Approval gates record who approved, when and why
Your experts
Today
Experts assemble, then review
- Finding and copying information from documents and systems
- Reconciling versions and checking what changed in the sources
- Formatting before the expert work can start
- Reconstructing which source supports which statement
With AriaFlow
AriaFlow assembles, experts decide
- A structured draft arrives with its evidence attached
- Gaps and conflicts are marked where they occur
- Review time goes to interpretation and decisions
- Approved corrections improve the template for next time
MedTech QA/RA
Technical documentation, V&V summaries, biological safety and clinical evidence summaries
Regulatory affairs
eCTD Modules 1 to 5 and pre-submission documents
Safety and pharmacovigilance
Periodic safety reports and other pharmacovigilance documents
Quality and GLP
Quality and manufacturing documents, GLP audits against rule sets
Product demos
See AriaFlow at work.
A template-led workflow from approved sources to a structured Word draft, with citations you can check and open points marked for your experts.
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Purpose-built capabilities
What sets AriaFlow apart.
Document Assembly
Less assembly. More judgment.
Each section is built from retrieved evidence, with citations and an evidence-coverage indicator. Missing information is stated, and conflicting sources are surfaced for your decision.
Template Ingestion
Your templates. Ready to use.
AI agents ingest the templates your team already uses, prepare the instructions behind each section and keep the output format. Experts refine the result instead of starting from scratch.
Expert-led Improvement
Expert knowledge is preserved.
Corrections in Word can turn into proposed template changes. People accept or dismiss them, test them and publish a new, immutable version. Nothing changes silently.
Connected Workflows
Workflows that follow your reality.
Document steps, reviews, approvals and decision gates in one workflow. Already in use for MedTech technical documentation and GLP audits against atomised rule sets.
Why not just use a chatbot?
Generating text is not the same as producing a governed document.
Chat assistants help with drafting and analysis. A controlled, repeatable document needs more around the text.
Our partners
A platform, plus the people who know what inspectors ask.
AriaFlow is delivered together with G&L Scientific and Entourage, one regulatory consultancy group. Its consultants help you choose the right documents, set up templates and make AI-supported document work stand up in an inspection.
Platform
AriaFlow GmbH
Product, template engineering and technical deep dives. Based in Mainz, Germany. The founders bring decades of experience in global pharmaceutical environments, including AI solutions.
How the platform works →Regulatory and delivery partner
G&L Scientific and Entourage
One group for regulatory affairs, pharmacovigilance, quality and life science project consulting across pharma, biotech and MedTech, with a strong presence in DACH through Entourage in Munich.
Security and inspection readiness
Built for the questions QA will ask.
Where does the data go, who can see it, and can you show how a document was produced? Here is how control works.
Your region, your data
Documents, derived data and audit records stay in the EU or US instance you choose, backups included.
No training on your content
Zero data retention at the model vendors. Customer content is not used to train or fine-tune models.
Full run record
Inputs, sources, template version and model are recorded for every run. State changes go to an append-only audit trail.
Approvals on record
Approval gates support multiple approvers and record identity, timestamp and reason.
Validation evidence
Versioned validation packs with every release, following a risk-based approach aligned with GAMP 5 and FDA CSA.
Access control
Single sign-on, multi-factor authentication, six defined roles and strict separation between organisations.
The shift is not from people to AI
Let's look at the document that costs your team the most hours.
Tell us which document type you have in mind. We will show you what a review-ready draft looks like and where your experts would step in.
- A live walkthrough on a document type close to yours
- With the AriaFlow team and an expert from G&L Scientific and Entourage
- Your questions on hosting, validation and audit trail answered on the call
Next step if it fits: a 4-week pilot on one or two of your document types, using your real sources. We measure cycle time, first-pass acceptance, evidence coverage and review rounds against your current baseline.
Book a 20-minute demo
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Or pick a time directly: open the booking calendar