AI Translation & Typesetting for CTD with Illustrations

X-doc AI employs a powerful two-step process designed for complex regulatory documents like the CTD. First, our advanced AI translates the text while intelligently preserving the original document's structure, including headings, tables, and basic layouts. For documents containing intricate illustrations, device schematics, or multi-column layouts, we offer an optional Post Typesetting service. This human-in-the-loop step involves professional formatters who manually refine the document to ensure every visual element is perfectly aligned and publication-ready, guaranteeing a submission-quality output.

Our platform is specifically engineered for the high stakes of regulatory submissions. Our AI models are trained on vast datasets of life science and pharmaceutical content, ensuring exceptional accuracy for specialized terminology. We understand that for regulatory reviewers, the preservation of data tables, charts, and nonclinical study illustrations is critical for clarity and efficient assessment. Furthermore, our enterprise-grade security, including end-to-end encryption and ISO certifications, ensures your sensitive intellectual property is protected throughout the translation process, meeting the stringent compliance demands of global health authorities.

Yes, our platform is built to manage large-scale, multi-document projects like a complete Common Technical Document dossier. You can efficiently translate all components, from Module 1's administrative information to the complex data in Module 3 (Quality), Module 4 (Nonclinical), and Module 5 (Clinical). Our system ensures consistent terminology is applied across all documents for uniformity and accuracy. By combining batch processing with our powerful format preservation engine, we streamline the translation of your entire submission package, significantly reducing manual rework and accelerating your timeline for global market access.

Post Typesetting is our professional manual formatting service designed to perfect the layout of your translated documents. While our AI does an excellent job of preserving standard formatting, you should use Post Typesetting for documents with highly complex visual elements. This includes CTD sections containing detailed manufacturing process diagrams, medical device schematics, complex clinical data tables, or specific corporate branding templates. It acts as the final quality check, where human experts ensure every illustration and text block is perfectly placed, delivering a polished, submission-ready file typically within 24 hours.

Accuracy is achieved through a combination of domain-specific AI and robust terminology management. Our neural translation engines are pre-trained on millions of pages of scientific, medical, and regulatory content, allowing them to understand context and specialized vocabulary. For each project, we can implement curated glossaries to ensure critical terms—such as drug names, chemical compounds, and clinical endpoints—are translated consistently every time they appear. This systematic approach eliminates ambiguity and ensures the final translation is not just linguistically fluent but also scientifically precise for an audience of regulatory experts.