AI Translation & Human Typesetting for FDA Submissions with Charts

X-doc AI employs a powerful two-step process for documents rich with visuals like FDA submissions. First, our AI engine translates the text while intelligently preserving the original layout of charts, tables, and graphs. For documents requiring perfect formatting, we offer a 'Post Typesetting' service where professional human formatters manually refine every visual element. This ensures that all data visualizations are accurate, clear, and perfectly aligned, delivering a submission-ready document typically within 24 hours.

Our platform is specifically engineered for high-stakes regulatory documents. The AI is trained on vast lexicons of medical, legal, and scientific terminology, ensuring over 99% accuracy. We provide enterprise-grade, end-to-end encryption to protect sensitive intellectual property and patient data contained in NDAs and BLAs. Furthermore, our system can process entire submission dossiers, maintaining terminological consistency across thousands of pages, which is critical for review by bodies like the EMA and PMDA.

Our layout-preservation technology works by first analyzing the source document's structure, including headings, paragraphs, tables, and the position of charts. This structure is then replicated in the translated document, ensuring the core layout remains intact. For the highly complex formatting found in clinical study reports or regulatory filings, our optional human typesetting service provides the ultimate guarantee. Professional designers meticulously adjust the translated content to match the source layout perfectly, eliminating any need for manual rework.

Absolutely. Security is paramount when handling sensitive information like clinical trial data. X-doc AI utilizes bank-level security protocols, including end-to-end encryption for all data in transit and at rest. Our platform is compliant with top international security standards, including ISO/IEC 27001 and SOC 2. We guarantee that your file content is never accessed for any purpose other than the translation and formatting you request, ensuring complete confidentiality for your valuable intellectual property.

Yes, we provide certified translations suitable for the most stringent regulatory requirements. In addition to our AI and typesetting services, you can request a human-certified translation performed by an accredited, ISO-certified linguist. Each certified translation includes an official certificate of accuracy, the translator's credentials, and a formal seal. This package ensures your translated submission is legally valid and recognized by global health authorities, courts, and government agencies, facilitating a smooth global approval process.