Meet ARIA. Your Regulatory Intelligence & Authoring Agent.
ARIA works alongside your team as you draft CMC documents and untangle large merged files, reading your LIMS exports, stability tables, and batch records, so nothing gets typed twice.
You're drowning in fragmented data, repeated authoring, and endless review cycles.
Regulatory complexity has increased. Your headcount hasn't.
More submissions, fewer writers
Teams are expected to produce more submissions with the same, or smaller, regulatory writing staff.
AI is changing expectations
What used to take weeks is now being benchmarked against what AI-native teams can do in days.
Legacy RIM wasn't built for this
Legacy systems were designed for storage and tracking, not intelligent authoring. ARIA pairs regulatory intelligence, semantic search across your own submission history, with cited, traceable authoring, so every drafted sentence points back to its source.
From raw data to a reviewer-ready draft.
Ingest raw files, not clean data
LIMS exports, scanned batch records, merged PDFs: ARIA's OCR engine parses layout and structure directly.
- Layout-aware OCR, tables intact
How ARIA splits one large merged file.
Most AI tools assume clean, structured data. LIMS exports, scanned batch records, and merged PDFs need to be parsed before a narrative can begin.
Solved by ARIA's proprietary OCR engineTeams often receive a single merged PDF spanning several modules, scanned, inconsistently formatted, with no metadata. ARIA's layout-aware OCR reconstructs structure first, then classifies and assigns each section, with its reasoning shown, not hidden.
§3.2.S.4.5
§3.2.S.4.5
§3.2.S.2
§3.2.S.4.4
§3.2.S.4.2
Module 1
ARIA drafts the section
Narratives generated for §3.2.S, §3.2.P, and Module 2.3 QOS, aligned to ICH M4Q(R1).
- Same-day first draft, source-traced
Your team reviews
Tracked changes, role-based approval gates, full audit trail. 21 CFR Part 11 built in.
- REVIEW
Export the eCTD backbone with validated hyperlinks and regional formatting applied automatically.
- FDA, EMA, PMDA, Health Canada ready
What ARIA Actually Handles
Six things your team is doing by hand right now.
OCR Processing & Structured Data Retrieval
Every accurate narrative starts with clean, structured source data, parsed directly from raw files.
Narrative auto-generation
Drafts Module 3 narratives using your approved language and templates.
Cross-section consistency
Flags every downstream section when a specification changes.
Stability table extraction
Pulls stability data and formats to ICH Q1E requirements.
Semantic reuse with traceability
Every reused block is traceable to source and approval date.
Multi-regional packaging
Multi-regional packaging
Inline validation before compile
Hyperlink and metadata checks run as you work.
What Actually Changes
ARIA builds institutional regulatory intelligence.
Every submission strengthens the next. ARIA connects source data, generated content, and regulatory guidance into one queryable knowledge layer, not just a document generator.
Cited down to the source
Every generated claim traces back to the exact paragraph, table, or figure it came from, not just which document.
Gap analysis against ICH
See what a module still needs, checked against the regulatory spec itself, not just what's already been filed.
Cross-submission diffing
See exactly what changed between one sequence and the next, instead of re-reading the whole filing.
Contradiction detection
Catch a spec limit stated one way in one section and differently elsewhere, before a reviewer does.
Classification confidence
See how confident ARIA is in a section assignment, and where two independent checks disagree.
Full audit trail
Every classification, edit, and approval is logged, so "what changed and who changed it" always has a real answer.
Wherever you sit in the process.
Emerging Biotech
Enterprise-grade authoring without an enterprise headcount.
- Fast implementation
- Scales with your pipeline
- No dedicated RIM team required
Mid-Size Pharma
Coordinate multi-program authoring without losing consistency.
- Cross-section consistency
- Multi-regional packaging
- Full audit trail, every program
CROs & Consultants
Deliver faster for every client without sacrificing rigor.
- multi client secured workflow
- Consistent output quality
- Faster turnaround per engagement
Integrate with the tools you already use.
Agentic AI
Search, Draft, Validate, and Publish agents work in concert.
IDP
Classify, extract, and normalize across labeling, CMC, and eCTD inputs.
Semantic Reuse
Insert approved language and tables with full traceability.
Governance
Audit logs, e-signatures, SSO, permissions, segregation of duties.
Already invested in your existing RIM? Add ARIA intelligence without replacing it.
ARIA augments the systems you already run, it doesn't ask you to rip and replace them.
Why regulatory affairs teams choose ARIA.
50 to 70% Faster Prep
Driven by intelligent workflow automation and semantic reuse.
Fewer Late-Stage Errors
Inline validation catches critical errors before the final compile.
Global Agility
Locale-aware rule sets and templates keep submissions globally compliant.
Phaseable RIM Replacement
Integrate with your existing stack now, consolidate later.
Why CIOs choose ARIA.
Enterprise adoption isn't just a regulatory decision. IT, security, and procurement need answers too.
Identity and access
SSO, role-based access, and granular permissions.
Deployment flexibility
Cloud or private deployment options to fit your governance model.
Audit and model governance
Full audit logs and visibility into how AI outputs are generated.
Tenant isolation
Your data stays segmented and private, never pooled across tenants.
Data residency
Hosted on AWS, with residency and disaster recovery built into the infrastructure.
No training on your data
Tenant data is never used to train underlying AI models.
Enterprise-grade security and compliance.
Trust is essential in regulatory work. ARIA is hosted on AWS, with CCPA and GDPR compliance built into the hosting layer, and strict boundaries on how your data is used.
Defense-in-depth
Encryption at rest, secure SDLC, segmented environments, and continuous monitoring on AWS infrastructure.
Your data is never used to train models
ARIA does not share tenant data with underlying AI models for training. Each tenant's data stays isolated and private.
CCPA and GDPR compliant
Compliance is built into the AWS hosting layer, with data residency and access controls maintained per tenant.
Things people ask before booking a demo.
Yes. ARIA connects via API to common LIMS and EDMS platforms and accepts standard export formats, plus Veeva Vault and SharePoint.
Yes. Audit logs, e-signatures, role-based access, and encryption are built into the platform, not bolted on.
FDA, EMA, PMDA, and Health Canada rule sets are built in, packaged from the same CMC content at export.
ARIA's document AI automatically structures, extracts, and classifies raw or merged inputs into the correct CTD sections, no manual pre-sorting required.
One workspace, five connected hubs.
Author
Module 3 narrative generation from source data, aligned to your approved language.
§3.2.S / §3.2.PClassify
Auto-assignment and classification of large merged files into CTD sections, with visible reasoning.
Document AIValidate
XML, hyperlink, and metadata validation before compile, catching errors early.
Pre-compilePublish
Multi-regional eCTD backbone assembly, packaged per authority automatically.
FDA / EMA / PMDATrack
Submission status and lifecycle tracking, a phaseable path off legacy RIM.
TraceabilityCMC Authoring In Practice
See what CMC authoring looks like when the data does the heavy lifting.
A 20-minute walkthrough. Your data, your use case, no obligation.