Regulatory intelligence infrastructure

One product.
Every market.
One controlled truth.

Artivex transforms pharmaceutical source evidence into international submissions, certificates, packaging, and market-ready outputs—through a traceable system built for regulatory work.

Explore the system
Source-connected Human-governed Built for pharma
SYSTEM ACTIVEARTIVEX / REGULATORY CORE
INTERNATIONAL SUBMISSIONCanada CTD → Market dossier
SOURCE
Canadian CTDApproved dossier and product evidence
Controlled
MAP
Deterministic crosswalkAuthoritative rules place candidate evidence
Applied
AI 01
Independent selectionBlind semantic review chooses its own set
Compared
AI 02
AdjudicationDifferences are re-evaluated with strict gates
Resolved
EVIDENCE LINKSSource → decision → output
Governed
REGULATORY DOSSIERPRODUCT INTELLIGENCEINTERNATIONAL SUBMISSIONSCERTIFICATESPACKAGING & ARTWORK
The operating system for regulated products

Pharmaceutical work is connected.
Your software should be too.

A source document can shape a submission, support a certificate, control a label, and appear in packaging. Artivex keeps those relationships intact—so teams stop rebuilding the same product truth across disconnected files and workflows.

THE FOUNDATION

A living regulatory record for every product.

Evidence, structure, decisions, markets, outputs, ownership, and history remain connected throughout the product lifecycle.

01Understand the sourceFiles become intelligence
02Decide with evidenceRules and AI stay auditable
03Adapt by marketOne core serves many structures
04Produce with controlEvery output keeps its lineage
A connected intelligence layer

From evidence to execution,
without breaking the chain.

Source intelligence

Know what every document is—and what it proves.

Import the effective dossier, preserve its original structure, and turn every file into traceable regulatory intelligence: purpose, document type, CTD position, product context, and lifecycle evidence.

Original files preservedDocument intelligenceControlled source map

Every decision remains connected to the document, destination, reason, confidence, and reviewer behind it.

International submission engine

Automation where it is reliable.
Human control where it matters.

Artivex does not ask one model to invent a dossier. It uses a governed sequence of deterministic rules, independent AI analysis, strict adjudication gates, leaf-level assessment, controlled generation, and validation.

ACTIVE MARKET STRUCTURES
PhilippinesACTD
Hong KongPRS 2.0

Structure-specific engines—not generic document conversion.

One platform, complete context

Built around how regulated products actually move.

Start with one high-friction workflow. The value compounds as every additional process reuses the same approved product evidence and operational context.

01

Regulatory dossier

Normalize CTD dossiers and lifecycle sequences. Classify, rename, retrieve, place, review, and trace every source file.

02

International registrations

Run market-specific source mapping, independent AI review, adjudication, assessment, generation, and package assembly.

03

Product intelligence

Keep strengths, manufacturers, sites, evidence, claims, market work, and regulated outputs connected to one product context.

04

Certificates and forms

Prepare CPP, GMP, fee forms, and related applications through structured, source-connected workflows.

05

Templates and artwork

Configure packaging templates, dielines, text styles, regulated content, review states, versions, and production exports.

06

Operational control

Coordinate teams, decisions, review queues, activity history, documents, costs, and company operations from one governed system.

Designed for consequential work

Intelligence that can show its work.

Speed is useful only when the source, reasoning, change, and authority remain visible. Artivex is built around evidence lineage and deliberate control.

Security and governance
01
Traceability

Follow every output back to its source evidence and decision history.

02
Controlled automation

Use deterministic rules, confidence gates, and explicit human review.

03
Versioned work

Preserve the effective source, mapping versions, reviews, and generated outputs.

04
Organization control

Keep access, actions, approvals, and operational ownership inside governed workspaces.

The next market starts with the source

Turn regulatory complexity
into controlled momentum.

See how Artivex connects your dossier, product intelligence, international submissions, certificates, templates, and artwork.