AI Translation for Regulatory Dossiers with Perfect Table Formatting

X-doc AI uses advanced layout-preservation algorithms to automatically detect and replicate the structure of tables within your regulatory documents. For highly complex data tables, such as those in clinical study reports or CMC sections, we offer a 'Post Typesetting' service. This human-in-the-loop feature involves a professional typesetter manually refining the table formatting to ensure 100% accuracy and visual consistency. This dual approach guarantees that all data, columns, and rows are perfectly aligned and ready for regulatory review, eliminating the risk of data misinterpretation.

Yes, our platform is specifically designed to handle large-scale projects like entire eCTD or CTD dossiers. You can translate all modules, from nonclinical and clinical study reports to quality and summary documents, in a single project. Our system maintains the critical structure, including bookmarks, hyperlinks, and table of contents, which is essential for navigable eCTD submissions. We combine AI-driven speed for the initial translation with optional expert review to ensure regulatory-grade quality across the entire submission package, accelerating your time-to-market.

Post Typesetting is our professional manual formatting service designed to perfect the layout of your translated documents. While our AI preserves formatting automatically, this service is ideal for documents with the most stringent layout requirements, such as multi-column patient information leaflets or clinical reports with intricate tables and embedded images. You should use it when your document must be publication-ready or meet the exact formatting standards of a specific health authority. The service is typically completed within 24 hours, providing a final, polished document without any manual rework on your end.

We ensure terminology consistency through a multi-layered approach that is critical for regulatory submissions. Our platform utilizes translation memory (TM) to store and reuse previously approved translations, ensuring terms are consistent across all documents in a dossier. We also build and manage client-specific glossaries containing key regulatory and scientific terms, such as those found in a Summary of Product Characteristics (SmPC). This process is overseen by subject-matter experts who validate the terminology, guaranteeing that every instance is accurate and compliant with regulatory standards.

Absolutely. We provide certified translations that meet the stringent requirements of global health authorities, including the FDA, EMA, and PMDA. Each certified translation package includes a formal Certificate of Accuracy signed by an ISO-certified linguist, attesting to the completeness and correctness of the translation. This documentation provides a clear audit trail and guarantees that your translated submission will be accepted by regulatory bodies. Our process ensures full compliance, giving you confidence in your global market authorization efforts.