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ServiceUpdated on 4 July 2025

eCTD services

About

Expert eCTD Sequence Creation & Publishing
Since 2017, our eCTD specialists have built hundreds of sequences for a broad range of applications (pre‑IND, IMPD, MAA/BLA, DMF/ASMF) submitted in regions such as the EU, US, Canada, Switzerland, Australia, New Zealand, South Africa and soon Ukraine

Document Formatting & PDF Publishing
We format documents with professional bookmarking, hyperlinking, headers/footers, and compliance with eCTD publishing specs using custom templates and high-quality software  Conversion from NeeS or Paper to eCTD
Our team converts legacy NeeS or paper dossiers into eCTD baselines, ensuring regulatory-acceptable structure for future updates

Validation & Technical Quality Control
We validate eCTD submissions, troubleshoot validation failures, and resolve technical XML or metadata issues to meet agency specifications

Gateway Publishing via Submission Portals
We handle dossier uploads to agency portals (e.g., EMA, FDA, Health Canada), including tracking and managing submissions through technical gateways

 eCTD v3 and Readiness for v4 & Country-Specific Requirements
We stay current with global requirements (eCTD v3.2.2 & upcoming v4.0), and tailor submissions to regional specifics and transition timelines

Tailored Project Packages
You can choose from flexible service tiers Ready to Build, Prepare & Build, or Full-Service—depending on your in-house capabilities and document formats.

Organisation

Starodub B.V.

Company (SME/startup) / 中小企業・スタートアップ

Nuland, Netherlands

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