Artivex

Artivex is an AI-native regulatory operations platform for bringing and maintaining pharmaceutical products across markets. For products entering a new market, Artivex understands the available product and regulatory information, prepares the CTD and submission package, structures it for eCTD workflows, and helps manage the submission process. After registration, the same connected product record remains the regulatory source of context, tracking submissions, certificates, commitments, labeling, product data, market status, and lifecycle changes. Instead of using separate tools and manual processes before and after approval, Artivex connects the regulatory journey from dossier preparation through submission and ongoing product maintenance.

Pharmaceutical companies still bring products to market through fragmented, manual regulatory processes. Teams assemble CTDs from information scattered across documents and systems, prepare market-specific submissions, manage eCTD requirements, respond to authorities, and then maintain the product after approval. Much of this work is repetitive, disconnected, and rebuilt market by market.