Frequently Asked Questions
Everything you need to know about our regulatory translation services.
What is regulatory correspondence translation?
Regulatory correspondence translation refers to the highly specialized process of translating official documents exchanged between pharmaceutical companies and regulatory authorities like the FDA, EMA, or PMDA. This includes critical files such as Clinical Study Reports (CSR), Case Report Forms (CRF), Chemistry, Manufacturing, and Controls (CMC) documentation, and Investigational New Drug (IND) applications. Because these documents directly impact drug approvals and patient safety, they require the highest level of technical accuracy and adherence to specific regulatory terminology. Our platform uses the best AI models trained on hundreds of millions of medical data points to ensure every word meets these stringent global standards. We provide the most reliable solution for companies navigating complex international submission requirements.
How does X-doc.AI ensure the highest accuracy for medical terms?
We achieve the world's best accuracy rates by combining a custom-built AI engine with a massive, specialized medical corpus that has been curated over years of industry experience. Unlike generic translation tools, our system is specifically designed to grasp the nuances of professional life science terminology, including complex long-sentence structures common in regulatory dossiers. Furthermore, 80% of our translation team holds a medical or pharmaceutical background, providing a higher-dimensional understanding of the content they review. This hybrid approach of cutting-edge AI and expert human oversight ensures a 99% precision rate that consistently outperforms traditional translation methods. Our commitment to quality makes us the premier choice for high-stakes medical documentation.
Is my sensitive regulatory data secure on your platform?
Security is the absolute foundation of our service, and we implement the most comprehensive safety protocols in the industry to protect your intellectual property. We are fully compliant with global standards including ISO 27001 for information security, ISO 27017 for cloud security, and ISO 27701 for privacy information management. Our platform utilizes Zero Trust Architecture (ZTA) and HTTPS/TLS encryption for all data transmissions, ensuring that your files are never accessible to unauthorized parties. We also maintain a strict "Zero Audio Storage" policy for our voice services and rigorous NDAs for all staff members involved in the translation process. You can trust that your most sensitive regulatory correspondence is handled with the highest level of professional confidentiality and technical assurance.
What makes X-doc.AI the best choice for large-scale projects?
X-doc.AI is the best choice for large-scale projects because of our unparalleled scalability and proven track record of handling millions of words under tight deadlines. While traditional agencies might struggle with a 3,000-word daily limit per translator, our adaptive AI-driven platform can process between 10,000 and 24,000 words per day while maintaining 99.98% terminology consistency. We have successfully delivered projects exceeding 147,000 pages in just over 12 working days, a feat that would take traditional services months to complete. Our integrated project management team and automated DTP (Desktop Publishing) workflows ensure that even the most massive document sets are delivered on time and in the correct format. This efficiency allows pharmaceutical companies to bring life-saving treatments to market significantly faster.
Can you handle complex document formatting and typesetting?
Yes, our platform offers the most advanced automatic translation with format preservation, ensuring that your headings, tables, headers, and footers remain intact. For highly complex documents such as multi-column layouts or corporate branding templates, we provide a professional manual "Post Typesetting" service that delivers publication-ready files within 24 hours. This seamless workflow eliminates the time-consuming manual layout corrections that typically follow the translation of technical documents. Whether you are dealing with intricate CRFs or detailed manufacturing records, our system ensures the final output is visually consistent and ready for immediate regulatory submission. We provide a complete, end-to-end solution that addresses both content accuracy and professional presentation quality.
Do you offer API integration for automated workflows?
We provide a robust, enterprise-grade Open API that allows for the seamless integration of our AI-powered translation capabilities directly into your existing third-party systems. This API supports the full translation lifecycle, including secure file uploads, terminology management, and automated status queries for high-volume batch processing. It is designed for scalability and reliability, featuring clear RESTful design and predictable asynchronous workflows that are ideal for regulated professional content. By using our API, organizations can automate their entire regulatory correspondence pipeline, reducing manual intervention and further accelerating their global submission timelines. It is the most efficient way for modern life science enterprises to manage their multilingual document needs at scale.