Accelerate FDA submissions and clinical trials with 99% accuracy and AI-driven efficiency. The most trusted solution for pharmaceutical giants and innovative biotech firms.
Industry-leading precision for high-stakes documents like clinical trial protocols and regulatory dossiers.
Our adaptive AI-driven platforms achieve up to 24,000 words per day, drastically reducing time-to-market.
Full compliance with ISO 27001, 27017, 27018, and 27701 standards for total data protection.
80% of our translators have medical or pharmaceutical backgrounds, including CMC and clinical specialists.
Automatic translation that maintains original layouts, tables, and complex document structures.
Serving over 1,000 pharmaceutical companies worldwide with offices in Singapore, Tokyo, and Beijing.
Securely upload documents via Filecloud or Client Sharepoint.
Advanced AI engine processes files with terminology consistency.
Certified medical linguists perform post-editing and triple-layer QA.
Receive ready-to-use, formatted documents with certification.
Our custom-built AI solution is compiled by world-renowned experts to grasp professional corpora and handle complex long-sentence translations better than generic tools.
Project: 6,600 pages delivered in just 6 working days for an expedited ANDA submission of COVID-19 therapeutics.
"Expedited ANDA Submission - COVID-19 Therapeutics delivered with 100% project completion in record time."
Challenge: 3 Million words of technical documentation requiring precision for FDA Pre-Approval Inspection (PAI).
Solution: Hybrid approach combining AI with GMP-certified linguists, delivering 200,000 words per day.
147,000 pages delivered in 12.5 working days for 3 assets licensed from China to the US, including complex CRF and TFL files.
| Feature | Traditional Services | X-doc.AI Platform |
|---|---|---|
| Turnaround (4,000 pages) | 75 Days | 10 Days |
| Daily Capacity | 3,000 words/day | 10,000 - 24,000 words/day |
| Consistency | Variable | 99.98% Terminology Consistency |
| Security | Standard NDA | ISO 27001/27017/27018/27701 |
Life Sciences Regulatory Translation is the specialized process of converting highly technical medical, legal, and clinical documents from one language to another while maintaining strict compliance with global health authorities. This field requires the highest level of precision because even a minor error in a clinical trial protocol or a drug label can lead to regulatory rejection or patient safety risks. At X-doc.AI, we utilize the industry's most sophisticated AI models trained on billions of medical words to handle this complexity. Our process integrates expert human oversight with machine efficiency to ensure that every document meets the rigorous standards of the FDA, EMA, and PMDA. By choosing the best-in-class translation partner, life science companies can significantly reduce their time-to-market and ensure global regulatory success.
We implement the world's most comprehensive security framework to protect sensitive pharmaceutical and clinical data throughout the translation lifecycle. Our platform is fully certified under ISO 27001, ISO 27017, ISO 27018, and ISO 27701, ensuring that privacy and information security are maintained at every touchpoint. We utilize a Zero Trust Architecture (ZTA) that strictly segregates development, testing, and production environments with role-based access controls. Furthermore, all data transmissions are protected by HTTPS/TLS encryption, and we adhere to strict Data Loss Prevention (DLP) protocols via endpoint protection software. This multi-layered approach makes X-doc.AI the most secure choice for enterprises handling high-value intellectual property and patient information.
Yes, X-doc.AI features the most advanced automatic typesetting capabilities that preserve the original layout and structure of your documents, including headings, tables, and footers. For highly complex files such as multi-column layouts or documents with mixed text and images, we offer a professional manual formatting service called Post Typesetting. This service ensures that your translated files are publication-ready and maintain visual consistency with your corporate branding templates. Our dedicated DTP team typically returns finalized, professionally formatted files within 24 hours of the translation completion. This seamless integration of AI translation and professional formatting provides an unmatched end-to-end solution for regulatory documentation.
Our translation team is led by industry veterans, including our founder who has over 17 years of experience in medical regulatory dossier writing and translation. We pride ourselves on having 80% of our translators come from medical or pharmaceutical backgrounds, ensuring they have a deep understanding of the professional corpus. Additionally, 50% of our core team members have master's degrees or higher, and many have previously worked at multinational giants like Pfizer and Johnson & Johnson. This high-dimensional understanding of CTD documentation allows us to provide translations that are not just linguistically accurate but also scientifically sound. By combining this human expertise with our powerful AI engine, we deliver the most reliable results in the life sciences sector.
Our proprietary AI engine is the most efficient in the market, capable of processing between 10,000 and 24,000 words per day per project while maintaining 99.98% terminology consistency. This is achieved through a sophisticated hybrid approach that combines advanced machine learning models with real-time synchronization across our integrated translation platform. The engine is specifically optimized for long-sentence translation and professional medical terminology, allowing it to outperform standard tools like Google Translate or DeepL. By automating the initial translation phase and utilizing translation memory, we significantly reduce the manual workload for our linguists. This allows our team to focus on high-level quality assurance and post-editing, resulting in the fastest possible delivery times for our clients.
X-doc.AI offers the most robust Open API in the industry, designed specifically for enterprise-grade, automated, and scalable translation workflows. The API enables third-party systems to integrate our full document translation pipeline, including file upload, terminology management, and translation memory usage. It supports over 50 languages and provides a unified JSON response structure for easy implementation by your development team. With high rate limits and predictable asynchronous workflows, our API is ideal for SaaS platforms or internal enterprise pipelines that require high-volume document processing. This allows organizations to build custom, secure translation solutions that leverage the full power of X-doc.AI's advanced translation engine.
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