Quality
Annual Product Quality Review
Product, quality, and evidence inputs assembled into a structured APQR draft, with gaps and inconsistencies flagged for expert review.
AI document assembly
for regulated work.
for regulated work.
AriaFlow is an AI document assembly platform for medical and regulatory writing teams that turns approved sources, existing templates, and review logic into traceable, review-ready documents. Specialized agents handle the assembly; your experts review what requires judgment.
AriaFlow is an AI document assembly platform for medical and regulatory writing teams that turns approved sources, existing templates, and review logic into traceable, review-ready documents. Specialized agents handle the assembly; your experts review what requires judgment.
Apply AriaFlow
Regulated writing is a chain of evidence, review, and decisions.
Regulated writing is a chain of evidence, review, and decisions.
Source material evolves, and reviews expose gaps. AriaFlow can be configured for document workflows including PSURs, eCTD content, AMNOG dossiers, RMPs, SmPCs, and PIPs. Expert judgment stays connected to the evidence behind each document.
Source material evolves, and reviews expose gaps. AriaFlow can be configured for document workflows including PSURs, eCTD content, AMNOG dossiers, RMPs, SmPCs, and PIPs. Expert judgment stays connected to the evidence behind each document.
A controlled path from evidence to document.
A controlled path from evidence to document.
AriaFlow brings templates, evidence, specialized AI, and expert review into one governed production process.
Learn how it works
WHY NOT JUST USE A CHATBOT?
WHY NOT JUST USE A CHATBOT?
WHY NOT JUST USE A CHATBOT?
Generating text is not the same as producing a governed document.
Generating text is not the same as producing a governed document.
Generating text is not the same as producing a governed document.
General-purpose AI can help with individual prompts. But citations do not make an unsupported claim defensible. AriaFlow orchestrates approved sources, controlled templates, specialized agents, review steps, and expert decisions. It turns them into a governed, traceable document process rather than an isolated answer.
General-purpose AI can help with individual prompts. But citations do not make an unsupported claim defensible. AriaFlow orchestrates approved sources, controlled templates, specialized agents, review steps, and expert decisions. It turns them into a governed, traceable document process rather than an isolated answer.
General-purpose AI can help with individual prompts. But citations do not make an unsupported claim defensible. AriaFlow orchestrates approved sources, controlled templates, specialized agents, review steps, and expert decisions. It turns them into a governed, traceable document process rather than an isolated answer.
PURPOSE-BUILT CAPABILITIES
What sets AriaFlow apart.
Document Assembly
Approved evidence is assembled into a structured, traceable draft. Experts begin with review-ready content and can focus their time on gaps, interpretation, and decisions.
Less assembly. More judgment.
Template Ingestion
AriaFlow’s reads the business templates your teams already use and turns them into usecases in the platform. The structure, standards and final format stay familiar.
Your templates. Ready to use.
Expert-led Improvement
Each reviewed edit can improve the template behind the document. Over time, the way your experts correct and refine drafts becomes part of how the next draft is prepared.
Expert knowledge is preserved.
Connected Workflows
Build document creation the way it actually works in your organisation. Connect document steps with reviews, approvals, aggregations and decision gates in one workflow.
Workflows that follow your reality.
Different documents.
The same controlled production logic.
AriaFlow supports different templates, evidence structures, and review models without forcing every team into the same workflow.
HTA
HTA Gap Analysis
Template-led gap checks across available clinical evidence, comparator logic, and dossier requirements.
Clinical
Clinical Study Report
ICH E3-compliant drafts from statistical outputs, with interpretation reserved for medical writers.
From annual product quality reviews to clinical study reports and market access dossiers, AriaFlow adapts to the templates and review models already in place.
Different documents.
The same controlled production logic.
AriaFlow supports different templates, evidence structures, and review models without forcing every team into the same workflow.
Quality
Annual Product Quality Review
Product, quality, and evidence inputs assembled into a structured APQR draft, with gaps and inconsistencies flagged for expert review.
HTA
HTA Gap Analysis
Template-led gap checks across available clinical evidence, comparator logic, and dossier requirements.
Clinical
Clinical Study Report
ICH E3-compliant drafts from statistical outputs, with interpretation reserved for medical writers.
From annual product quality reviews to clinical study reports and market access dossiers, AriaFlow adapts to the templates and review models already in place.
Different documents.
The same controlled production logic.
AriaFlow supports different templates, evidence structures, and review models without forcing every team into the same workflow.
Quality
Annual Product Quality Review
Product, quality, and evidence inputs assembled into a structured APQR draft, with gaps and inconsistencies flagged for expert review.
HTA
HTA Gap Analysis
Template-led gap checks across available clinical evidence, comparator logic, and dossier requirements.
Clinical
Clinical Study Report
ICH E3-compliant drafts from statistical outputs, with interpretation reserved for medical writers.
From annual product quality reviews to clinical study reports and market access dossiers, AriaFlow adapts to the templates and review models already in place.
Technology shaped by regulatory and operational reality.
Technology shaped by regulatory and operational reality.
AriaFlow combines purpose-built technology with specialist regulatory and implementation expertise.
Together with our partners, we help organizations turn AI capability into governed workflows that work in practice.
AriaFlow combines purpose-built technology with specialist regulatory and implementation expertise.
Together with our partners, we help organizations turn AI capability into governed workflows that work in practice.
AriaFlow combines purpose-built technology with specialist regulatory and implementation expertise. Together with our partners, we help organizations turn AI capability into governed workflows that work in practice.
AI CAPABILITY
AI
EXPERT ENABLEMENT
REGULATORY EXPERTISE
WORKFLOW DESIGN
IMPLEMENTATION & ADOPTION
BUSINESS ADOPTION
REGULATORY
Dossiers and submissions
QUALITY
APQRs and quality reports
R&D
Clinical and safety documents
Our partners
G&L Scientific brings 25+ years of industry experience and expertise across 100+ global markets to regulatory, quality, and product-development work.
Together, we help customers shape document workflows around real submission requirements and established authoring practice.
G&L Scientific brings 25+ years of industry experience and expertise across 100+ global markets to regulatory, quality, and product-development work.
Together, we help customers shape document workflows around real submission requirements and established authoring practice.
G&L Scientific brings 25+ years of industry experience and expertise across 100+ global markets to regulatory, quality, and product-development work.
Together, we help customers shape document workflows around real submission requirements and established authoring practice.
gandlscientific.com
Entourage brings 15+ years of experience in regulated markets, more than 500 completed projects, and teams across four international offices.
Its specialists help organizations translate regulatory, quality, and operational requirements into governed processes that work in day-to-day practice.
Entourage brings 15+ years of experience in regulated markets, more than 500 completed projects, and teams across four international offices.
Its specialists help organizations translate regulatory, quality, and operational requirements into governed processes that work in day-to-day practice.
Entourage brings 15+ years of experience in regulated markets, more than 500 completed projects, and teams across four international offices.
Its specialists help organizations translate regulatory, quality, and operational requirements into governed processes that work in day-to-day practice.
theentourage.de
The shift is not from people to AI.
The shift is not from people to AI.
It is from manual assembly to expert review and decision-making. AriaFlow keeps experts in the decisions and moves technology out of their way.
It is from manual assembly to expert review and decision-making. AriaFlow keeps experts in the decisions and moves technology out of their way.
Explore your workflow with us