Qtes eCTD Builder
Qtes eCTD Builder is a suite of integrated software products for the creation, manipulation, validation, publishing and viewing of regulatory documentation — built for pharmaceutical companies submitting electronically to regulatory authorities worldwide.
Qtes eCTD Builder covers the full submission lifecycle in a single desktop application — from organizing source files to producing a validated, archived, ready-to-transmit dossier.
System requirements: Windows 7 or later · Microsoft .NET runtime.
Five core capabilities, one toolchain — purpose-built for pharma regulatory affairs teams.
Six capability areas that work together — from organizing source files to producing a validated, archived, ready-to-transmit dossier.
Move files & directories into the submission while keeping the original structure intact. Easy to find, view and audit submissions; history is preserved with date-time-stamped archives and optional cloud backup.
Dossiers are automatically created and sorted by authority, agency, purpose and applicant name. A lifecycle view shows all sequences together — current sequence files alongside every previous sequence under the same submission.
Compile submissions according to the selected authority's procedure. Build and fill the eCTD XML backbone — IDs, checksums, href links and all required attributes — with the option to validate existing or imported submissions.
Publish the compiled submission to a defined path with a generated PDF Table of Contents, envelope and validation report. Submissions are archived as compressed instances with date-time names. Publishing is blocked until the submission is compiled and locked.
On-spot validation runs during submission building, so issues surface early. A validation report is generated and archived every time validation runs — providing a permanent audit trail for every dossier you produce.
Built-in PDF toolkit: hyperlink & bookmark fixer and creator, file splitter, file compression, file comparison, and a "Fix PDF" tool that automatically resolves common issues to meet authority requirements.
Restricted, role-based permissions control who can add, delete or unlock submissions. Deleting or unlocking published submissions requires confirmation from all authorized admins — so important work is never lost or overwritten by mistake.
Qtes eCTD Builder restricts and manages human actions automatically — controlling file and folder naming, structure, UUID and checksum generation, related file IDs, file type and format checks, and PDF properties — to eliminate common sources of validation errors before they happen.
Each product works standalone — or connects to share data, governance and audit trails across your regulatory and quality teams.
Structured authoring and publishing for electronic Product Information and FDA Structured Product Labeling — leaflets, SmPCs, package inserts and labels.
A collaborative, cloud-based Quality Management System with modules for File Control, Change Control, Training, CAPA, Deviation and Audit.
Book a tailored demo focused on the authorities, submission types and lifecycle scenarios that matter to your team.
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