Empowering pharmaceutical and medical device leaders with AI-driven precision, ISO-certified security, and rapid turnaround for high-stakes regulatory dossiers.
Unparalleled quality and security for your most sensitive documentation.
Industry-leading translation precision specifically optimized for professional medical and pharmaceutical corpus.
Full compliance with ZTA standards, strictly segregating development and production environments with role-based access.
Achieve 10,000 to 24,000 words per day per translator, significantly outperforming traditional industry benchmarks.
Securely upload documents via Filecloud or Client Sharepoint.
Advanced AI engines process text with deep context awareness.
Certified medical linguists perform post-editing and QA.
Receive formatted, ready-to-use regulatory documents.
Precise translation for global clinical research documentation.
Compliance-ready dossiers for international market authorization.
Accurate safety reporting and adverse event documentation.
Technical chemistry, manufacturing, and controls data.
Multilingual instructions for use and technical specifications.
Protecting intellectual property across global jurisdictions.
For an expedited ANDA submission for COVID-19 therapeutics, our team delivered 6,600 pages in just 6 working days. This included pre-translation formatting and 100% project delivery within a critical timeline.
"The speed and precision allowed us to meet regulatory deadlines that seemed impossible."
We managed 3 million words of technical documentation for an FDA Pre-Approval Inspection (PAI). Our hybrid approach combined AI with GMP-certified linguists to deliver 200,000 words per day with flawless accuracy.
In just 12.5 working days, we delivered approximately 147,000 pages of CSR, CRF, and TFL documentation. This massive scale was handled through automated PDF-to-Word processing and expert PM oversight.
| Feature | Traditional Services | X-doc.AI Platform |
|---|---|---|
| Daily Capacity | ~3,000 words/day | 10,000 - 24,000 words/day |
| Accuracy Rate | Variable (Human error) | 99.98% Consistency |
| Security Standards | Basic NDA | ISO 27001, 27017, 27018, 27701 |
| Format Preservation | Manual Re-typing | Automatic AI Typesetting |
Global Clients
Words Translated
Client Satisfaction
AI & Medical Experts
Secure regulatory document translation refers to the highly specialized process of converting technical pharmaceutical and medical documentation from one language to another while maintaining absolute data integrity and compliance. This process is essential for companies submitting dossiers to global regulatory bodies like the FDA or EMA, where any error can lead to significant delays or rejections. At X-doc.AI, we utilize advanced AI models trained on hundreds of millions of medical corpora to ensure that every term is translated with 99% accuracy. Our platform is built on a Zero Trust Architecture, ensuring that sensitive clinical data is never exposed to unauthorized parties during the translation lifecycle. By combining cutting-edge technology with expert human review, we provide the most reliable solution for high-stakes life science documentation.
X-doc.AI stands out as the premier choice because it is specifically engineered for the rigorous demands of the life sciences industry rather than being a general-purpose translation tool. Our leadership team includes former heads of medical writing from global giants like Johnson & Johnson and Pfizer, bringing decades of regulatory expertise to our platform's development. We offer a unique hybrid approach that leverages powerful AI for speed and certified medical linguists for nuanced quality assurance, ensuring 99.98% terminology consistency. Furthermore, our platform is trusted by over 1,000 global pharmaceutical companies, including multinational leaders like Bayer, Roche, and MSD. This combination of deep industry knowledge, massive technical scale, and proven success makes us the most authoritative partner for your regulatory translation needs.
Our platform is designed to handle massive volumes of documentation, such as CTD dossiers and clinical study reports, with unprecedented efficiency and speed. We utilize an integrated translation engine that allows for real-time synchronization across large teams, enabling us to process up to 24,000 words per day per translator. As demonstrated in our case studies, we have successfully delivered over 147,000 pages of complex documentation in just 12.5 working days, a feat that traditional services would take months to complete. The system includes automated PDF-to-Word processing and format preservation, which eliminates the time-consuming manual re-typing often required for regulatory files. This scalable infrastructure ensures that even the largest projects are delivered on time without compromising the precision required for regulatory approval.
X-doc.AI maintains the highest level of international security and privacy certifications to protect our clients' intellectual property and sensitive patient data. We are fully certified under ISO/IEC 27001 for Information Security Management, ISO/IEC 27017 for Cloud Security, and ISO/IEC 27018 for the protection of PII in public clouds. Additionally, we hold ISO/IEC 27701 for Privacy Information Management and are certified under the Information System Security Level Protection framework by the Ministry of Public Security. Our translation processes are also governed by ISO 17100 and ISO 18587 standards, ensuring that our service quality meets global benchmarks for professional translation. These comprehensive certifications demonstrate our unwavering commitment to maintaining a secure and compliant environment for all regulatory translation tasks.
Our AI achieves industry-leading accuracy by utilizing a custom-built solution that has been trained on an enormous professional corpus consisting of hundreds of millions of medical data points. Unlike generic AI models, our engine is optimized to grasp complex professional terminology and long-sentence structures common in clinical and non-clinical research. The platform also incorporates smart long-term memory, which allows it to learn and remember your company's specific industry jargon and context over time. Every AI-generated translation undergoes a rigorous triple-layer QA protocol involving certified medical linguists, many of whom hold master's degrees or higher in pharmaceutical fields. This synergy between advanced machine learning and human expertise ensures that the final output meets the exacting standards required for successful regulatory submissions.
Data privacy is the foundational pillar of the X-doc.AI platform, and we implement strict operational controls to guarantee the confidentiality of every document. We adhere to a Zero Trust Architecture, which means that development, testing, and production environments are strictly segregated with role-based access controls. All staff members are required to sign non-disclosure agreements and undergo mandatory security training, while all activity on the platform is logged in real-time for audit purposes. We also employ Data Loss Prevention protocols and HTTPS/TLS encryption to ensure that data remains secure during transmission and at rest. Our commitment to privacy is further reinforced by our ISO 27701 certification, ensuring that we meet the most stringent global standards for privacy information management.
Join over 1,000 global leaders who trust X-doc.AI for their most critical translation needs. Experience the best-in-class precision today.
Get Started Now