One product record. Every regulated workflow.
Identity, strengths, manufacturers, sites, dossiers, markets, certificates, content, owners, approvals, and outputs remain connected across the lifecycle.
Regulatory operations infrastructure for pharmaceutical teams
One product record.
Every regulated workflow.
Connect product data, regulatory dossiers, international submissions, certificates, approved content, packaging templates, artwork, and human approvals—from source evidence to market-ready output.
SOURCEApproved evidenceTraceableDESTINATIONMarket-ready outputReviewableHuman approved
LIVE PRODUCT WORKSPACEPRODUCTS · DOSSIERS · MARKETS · OUTPUTS
Source-linked evidence Lifecycle-aware dossiers Human approval built in
PRODUCT INTELLIGENCECTD & eCTDMARKET SUBMISSIONSCERTIFICATESCONTENT & ARTWORK
One controlled product record
Stop rebuilding the same product truth for every workflow.
The same approved facts and evidence support registrations, certificates, labels, packaging, and portfolio decisions. Artivex keeps the product, source, requirement, decision, and output connected across teams and markets.
01
Control the productConnect facts, sites, strengths and marketsKeep the complete product context visible and reusable.
02
Understand the sourceMake every dossier sequence searchablePreserve original files, lifecycle structure and regulatory purpose.
03
Execute the workflowPrepare submissions, certificates and artworkCarry approved facts forward with evidence lineage intact.
04
Govern the outcomeKeep humans, reasons and versions visibleApprove, reject and trace each consequential change.
Purpose-built workspaces
The connected operating layer around every regulated product.
Each workspace is purpose-built for its task. Product facts, source evidence, destination requirements, ownership, decisions, and history remain shared underneath.
01 · DOSSIER INTELLIGENCE
Turn CTD and eCTD lifecycles into reusable intelligence.
Preserve every imported sequence and the effective dossier, understand each document, and retrieve evidence by regulatory purpose instead of searching folders by hand.
Explore this workflow
02 · INTERNATIONAL SUBMISSIONS
Prepare each destination from approved source evidence.
Apply the authority profile, compare candidate evidence, adjudicate uncertainty, assess every requirement, and generate a controlled package for review.
Explore this workflow
03 · CONTENT, TEMPLATES & ARTWORK
Carry approved content all the way to production artwork.
Structure product content, configure reusable templates, map physical dielines and panels, and preserve every generated version through review and export.
Explore this workflow
A connected intelligence layerFrom evidence to execution,
From evidence to execution,
without breaking the chain.
Keep the complete regulated product in one living record.
Connect product identity, strengths, dosage forms, manufacturers, sites, market status, certificates, dossiers, approved content, owners, and activity instead of rebuilding the context in every system.
Portfolio-wide visibilityStructured product factsShared operational context
Market submission engineAutomation where it is reliable.
Automation where it is reliable.
Human control where it matters.
Artivex uses a governed sequence of rules, bounded AI analysis, adjudication gates, requirement-level assessment, controlled generation, and validation. Missing evidence remains visible; consequential outputs remain reviewable.
STANDARDIZED SERVICE MODEL
Source profileEvidence ready
Market profileRequirements ready
One governed workflow, configured to the destination authority.
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
Portfolio oversight
See product readiness, market work, dossier status, certificates, approvals, owners, and items requiring attention across the portfolio.
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 governance01
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.
Bring the whole product lifecycle into viewTurn fragmented product work
Turn fragmented product work
into controlled momentum.
See how Artivex connects product intelligence, CTD and eCTD evidence, international submissions, certificates, approved content, packaging templates, artwork, and approvals.