eCTD, Qtes ePI & eSPL Builder and Qtes eQMS are designed to work standalone — and even better together. Each is production-grade, validation-ready, and shaped by years of real-world regulatory practice.
An integrated software suite for the creation, manipulation, validation, publishing and viewing of eCTD submissions. Standalone Windows desktop application.
Author, version and publish electronic Product Information and FDA Structured Product Labeling — leaflets, SmPCs, package inserts and labels — in the structured formats regulators expect.
A collaborative, cloud-based Quality Management System. Modules for File Control, Change Control, Training, CAPA, Deviation and Audit — all in one connected platform.
Run our products standalone, or connect them so your dossiers, product information and quality processes share data — not just folders.
One identity across Qtes eCTD Builder, Qtes ePI & eSPL Builder and Qtes eQMS — with consistent role-based permissions.
A common reference for products, presentations and markets — used across all three systems.
From a QMS change control to an ePI update and an eCTD variation — fully traceable, end to end.
Book a tailored demo with our product specialists — focused on the use cases that matter to your team.
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