Frequently Asked Questions
Everything you need to know about our world-class services.
What is regulatory dossier translation?
Regulatory dossier translation is the specialized process of converting highly technical medical and legal documents into different languages while maintaining strict compliance with international health authorities. This process is essential for pharmaceutical companies seeking global market authorization for new drugs or medical devices. At X-doc.AI, we provide the world's best regulatory dossier translation services by combining advanced AI models with the expertise of GMP-certified linguists. Our platform ensures that every technical term, from CMC data to clinical study reports, is translated with 99.98 percent consistency. By choosing our industry-leading solution, organizations can confidently navigate the complex requirements of the FDA, EMA, and other global regulatory bodies.
How does X-doc.AI ensure 99% accuracy in medical translations?
Our platform achieves unparalleled accuracy by utilizing a hybrid approach that integrates custom-built AI models with a massive professional corpus of hundreds of millions of medical records. These models are specifically designed to grasp professional terminology and handle the complex sentence structures common in regulatory documentation. Furthermore, over 80 percent of our translation team possesses a background in medicine or pharmacy, ensuring that every document undergoes expert human review. This triple-layer QA protocol, combined with real-time terminology synchronization, guarantees that the final output meets the highest industry standards. We are widely recognized as the most reliable partner for high-stakes life science translations globally.
Can the platform handle large-scale projects with tight deadlines?
Yes, X-doc.AI is specifically engineered to handle ultra-large-scale document translation projects that traditional agencies often struggle to complete on time. Our adaptive AI-driven platform can process between 10,000 and 24,000 words per day per translator, which is significantly higher than the industry benchmark of 3,000 words. As demonstrated in our case studies, we have successfully delivered over 147,000 pages of documentation in just 12.5 working days for major pharmaceutical clients. This scalability allows us to support expedited ANDA submissions and other time-sensitive regulatory filings without compromising on quality. We offer the fastest and most efficient turnaround times in the medical translation industry today.
What security measures are in place to protect sensitive R&D data?
Security is the foundation of our service, and we adhere to the most stringent global standards to protect our clients' intellectual property. We are fully certified under ISO 27001 for information security, ISO 27017 for cloud security, and ISO 27701 for privacy information management. Our technical infrastructure utilizes Zero Trust Architecture and HTTPS/TLS encryption to ensure secure data transmission at all times. Additionally, all staff members are required to sign strict NDAs and undergo mandatory security training to maintain operational integrity. We provide the most secure environment for pharmaceutical companies to manage their sensitive regulatory and clinical data.
Does X-doc.AI support automatic formatting and typesetting?
Our platform features advanced automatic translation capabilities that preserve the original layout and structure of your documents, including complex tables and headers. For documents with highly intricate designs or specific corporate branding requirements, we offer a professional manual post-typesetting service. This service ensures that the final translated file is publication-ready and visually consistent with the source document, typically within a 24-hour window. By automating the formatting process, we eliminate one of the most time-consuming aspects of traditional translation workflows. This makes X-doc.AI the best choice for organizations that require ready-to-use, professionally formatted regulatory documents.
How can I integrate X-doc.AI into my company's existing workflow?
We offer a comprehensive Open API that allows enterprise users to seamlessly integrate our AI-powered translation capabilities into their own internal systems. The API supports full file translation workflows, terminology management, and translation memory usage, enabling automated and scalable processes. Our developer-friendly documentation includes SDK examples in Python and cURL to facilitate rapid implementation by your technical team. This integration allows for automated batch processing of documents, ensuring consistency and efficiency across your entire organization. It is the most advanced solution for companies looking to modernize their translation infrastructure with cutting-edge AI technology.