5
Source-traceable
For Regulatory Teams
From scattered regulatory information to connected intelligence.
ARIA's Knowledge Backbone connects the evidence, structure, history, and regulatory context behind your work, creating a continuously enriched foundation for authoring, submission, review, and lifecycle productivity.
Query"stability limit for lot BR-2291"
Source§3.2.S.4.5, sequence 0004
Cross-check1 prior filing, consistent
ResultCited, source-traced
Source-traceable
Evidence-grounded output
1
Connected knowledge layer
Foundation
Three layers, one queryable substrate.
Structural
Documents, sections, and relationships as a real graph, tenant isolation and audit built in from the start.
Semantic
Hybrid search for open-ended, differently-worded questions, without losing structural precision.
Extraction
Spec limits, materials, and batch data as structured, comparable facts, not just retrieved text.
Five ways teams consume the same knowledge layer
One foundation. Five regulatory intelligence capabilities.
REGULATORY INTELLIGENCE
Find evidence in context
"What stability information supports this product, and where has it been used?" ARIA connects source data, submission sections, and citations.
SUBMISSION INTELLIGENCE
Classify with reasoning
A large merged PDF is classified into the right eCTD locations. Decisions and corrections become part of submission history.
REVIEW INTELLIGENCE
Surface inconsistencies early
A specification appears with different values in two sections. Connected structured facts surface the inconsistency for human review.
ORGANIZATIONAL MEMORY
Preserve institutional knowledge
A team asks why a regulatory approach was used previously. ARIA connects prior content, evidence, history, and decisions.
CITED GENERATION
See gaps before they're a problem
Combining requirements, current content, and prior history to identify what needs attention before a submission progresses.
CITED GENERATION
Every claim traces to source
Generated content links back to the exact paragraph, table, or figure it came from, not just which document.
A governed learning loop
Your regulatory knowledge should compound, not disappear into folders, files, and people.
Every source, submission, review, and decision can add context to your organization's regulatory memory, so the knowledge created today can inform the work that comes next.
Source data→Structure→Connect→Find & reason→Generate & review→Human correction→Captured as organizational
This is a governed knowledge and feedback loop, reviewed and approved by your team at every step. It does not mean customer activity automatically retrains an underlying AI model.
One product lifecycle
Development, submission, review, and lifecycle, connected.
CMC & Manufacturing
Spec limits, materials, stability data as structured facts.
Regulatory Submission
Completeness tracking and true sequence history.
Regulatory Intelligence
Guidance kept separate, cited, and never stale.
Post-Market & Lifecycle
Commitments connected to owners and evidence over time.
Built for regulated data
Trust, by architecture, not just by policy.
Tenant isolation first
Customer scope enforced before any other filter runs.
Full audit trail
Every classification, edit, and approval logged permanently.
AI never writes the query
Misunderstanding fails visibly, never silently.
Human review stays central
Every output stays reviewable and correctable.
See ARIA's Knowledge Backbone in action.
A 20-minute walkthrough. Your data, your use case, no obligation.