Qtes ePI & eSPL Builder
Author, version and publish electronic Product Information and FDA Structured Product Labeling — leaflets, SmPCs, package inserts and labels — in the structured formats regulators are moving toward worldwide.
Move from document-shaped product information to structured, query-ready data. Author once, then publish to every audience — regulators, healthcare providers and patients — in the formats each one needs.
Move from document-shaped product information to structured, query-ready data.
A single content model, encoded in the structures each authority and audience demands.
Structured Product Labeling — the FDA's XML format for labeling, leaflets and package inserts. Native authoring and validation, with publishing-ready output for FDA submissions.
Structured electronic Product Information aligned with EMA's ePI framework and HL7 FHIR resources — for query-ready, machine-readable product data.
Identification of Medicinal Products data structures — so product master data stays consistent across submissions, labeling and pharmacovigilance.
Each product works standalone — or connects to share data, governance and audit trails across your regulatory and quality teams.
An integrated suite for creation, manipulation, validation, publishing and viewing of eCTD dossiers — for FDA, EMA, GCC and emerging-market authorities.
A collaborative, cloud-based Quality Management System with modules for File Control, Change Control, Training, CAPA, Deviation and Audit.
Book a tailored demo of structured authoring, multi-market versioning and regulator-ready publishing.
Request a demo