Accelerate regulatory submission with AI your team can trust.

Accelerate regulatory submission
with AI your team can trust.

AriaFlow drafts your submission from your own templates and source data. Flags everything that needs your experts attention. Your team reviews, decides, and signs off. Experts remain in control at every stage.

See it with your templates

Behind every drug approval are thousands of documents, dozens of systems, and months of manual work.

A single regulated submission can involve more pages than the entire English Wikipedia printed as books. Every one of those pages is assembled by hand, from data scattered across systems that don’t talk to each other.

PSUR

eCTD

AMNOG

RMP

SmPC

PIP

1M+

Pages per submission

Regulatory packages span thousands of documents, multiple modules, and millions of individual data points - all of which must be coherent, consistent, and cross-referenced.

8–15

Source systems per dossier

Veeva, SAP, LIMS, ERP, SharePoint, clinical databases, PDFs, EMA/FDA guidelines - none of which talk to each other. Your team bridges every gap manually.

100h

Drafting effort per submission

~18,870 pages of input data per dossier, pulled and structured by hand. That’s time your medical writers and RA managers spend on assembly - not on science.

€1–2M

Revenue lost per week of delay

Every week a submission slips costs your pipeline real money. And 1–2% of submissions still fail on technical validation alone - errors that systematic assembly eliminates.

Your competitors are already using AI in submissions. What’s your plan?

The industry has moved. Regulators have moved. The question is no longer whether AI belongs in your submission pipeline,

it’s whether you can adopt it without losing the expert control that makes submissions defensible.

The industry has moved. Regulators have moved. The question is no longer whether AI belongs in your submission pipeline,

it’s whether you can adopt it without losing the expert control that makes submissions defensible.

The industry

81%

of pharma companies now deploy AI

80% of top pharma companies are actively modernising their regulatory information management systems. Pharma AI investment grows from $4B in 2025 to $25.7B by 2030.

A top-5 pharma company partnering with a leading strategy firm cut first-draft CSR writing time from 180h to 80h - a 55% reduction"

McKinsey 2025 Regulatory Benchmark

The regulator

Elsa 4.0

FDA’s AI — now reading your submission

In June 2025, the FDA launched Elsa an AI designed to review submissions, surface inconsistencies, and identify inspection targets faster. In January 2026, FDA and EMA jointly published Guiding Principles of Good AI Practice in drug development. Submissions that are traceable, consistent, and source-cited will be processed faster. Those that aren’t will face greater scrutiny.

FDA.gov June 2025; FDA–EMA Joint Guiding Principles January 2026

The cost of waiting

40%

faster end-to-end CSR cycle times with AI

Teams still assembling dossiers manually are not just slightly slower. They are structurally disadvantaged compared with competitors using AI-assisted production. A 55% reduction in drafting time translates directly into earlier submission dates and earlier revenue recognition. The opportunity to implement these capabilities thoughtfully, before time pressure becomes acute, is now.

McKinsey 2025 Regulatory Affairs Benchmark

The cost of waiting

40%

faster end-to-end CSR cycle times with AI

McKinsey 2025 Regulatory Affairs Benchmark

Built for pharma

Every capability designed around regulated submissions.

Not a general-purpose AI tool adapted for pharma. A document production system built from the ground up around the constraints, workflows, and quality standards of regulatory submissions.

Document Assembly

Audit-ready drafts from your templates and connected data. AriaFlow handles the 80% that is mechanical. Your experts own the 20% that requires judgment.

Select a report or submission type

Link source documents and data

Generate submission drafts in minutes

Faster output. Full traceability.

Template Ingestion

Upload your existing approved templates. AriaFlow converts them into structured production processes with defined placeholders and conditional logic - your standards, exactly.

Import your Word
template

AriaFlow builds logic and placeholders

Review, adapt and start generation.

Your standards enforced. Rework eliminated.

Template Optimization

Expert edits are analysed and proposed back to the master template. Institutional knowledge doesn’t leave the company when people do.

Upload corrected document

Review AriaFlows prompt optimization

Generate improved
submissions.

Knowledge stays. Expertise compounds.

Workflow Orchestration

Multi-step review chains - author, medical, legal, RA sign-off - with human approval at every stage. Document outputs feed directly into downstream workflows.

Load regulatory templates

Link inputs, systems and add review steps

Run your document value chain

End-to-end. Enterprise scale.

From eCTDs to HTA
AriaFlow is built for
real pharma workflows.

AriaFlow supports the regulated document types, review processes, and enterprise systems already used by regulatory affairs, medical writing, and market access teams.

Document types

eCTD / CTD

Common Technical Document

Modules 1–5 assembled from clinical and quality data. Cross-module inconsistencies flagged before RA review. Ready for FDA, EMA, PMDA.

AMNOG §35a

AMNOG Benefit Dossier

G-BA structure pre-built. Evidence pulled from CSRs and cross-referenced. Benefit qualification sections flagged for medical affairs.

EU HTA

Joint Clinical Assessment

EUNETHRA-aligned templates with HTA GAP Analysis. Clinical interpretation sections flagged for your medical affairs team.

Quality

Quality Overall Summary

Module 2.3 QOS from CMC data. Terminology checked against your glossary — every deviation surfaced before QA review.

Clinical

Clinical Study Report

ICH E3-compliant drafts from statistical outputs. AriaFlow handles the scaffold. Medical writers focus on interpretive sections.

Regulatory

Variations & Package Inserts

Label updates and lifecycle submissions. Every deviation from the last approved version flagged for RA sign-off.

These examples illustrate common supported pharma use cases. AriaFlow supports your existing templates, document structures, and internal standards without requiring teams to rewrite how they work.

Regulatory standards

Pre-configured for the submission structures, guidance documents, and compliance requirements that govern modern pharmaceutical development.

ICH CTD / eCTD

Module structure aligned to ICH M4 for EMA, FDA, PMDA, and national authorities.

AMNOG §35a

G-BA mandatory module structure and evidence templates.

EU HTA 2021/2282

JCA templates covering PICO and Joint Scientific Consultation structures.

21 CFR Part 11

Electronic records and signatures with full audit logs and version history.

ICH E3 (CSR)

Clinical study report structure with auto-populated sections from statistical outputs.

GxP-Ready

Validation documentation and qualification support available.

Integrations

Native MCP connectivity. No middleware, no custom ETL. AriaFlow pulls from your existing systems as well as public sources and cites every source it touches.

Microsoft Word

SharePoint

LIMS

OpenFDA

WHO ATC

OpenText

EudraVigilance

ClinicalTrials.gov

NICE

Bio Ontology

ChEMBL

DailyMed

EMA

medRxiv

Custom APIs

AI accelerates submissions. Experts keep them defensible.

AriaFlow automates the mechanical work, surfaces uncertainties, and keeps medical and regulatory experts in control of every critical decision.

Accelerate regulatory submission with AI your team can trust.