Accelerate your global market entry with AI-native translation workflows that deliver 99.9% accuracy and 92% faster turnaround times than traditional CROs.
Our custom-built AI solution is fine-tuned for long-sentence medical translation and complex regulatory terminology.
Process 4,000 pages in just 10 days, compared to the 75-day industry standard for traditional translation services.
Fully compliant with ISO 17100:2015 and ISO 18587:2017 for high-quality translation and post-editing output.
70+ full-time translators with 80% holding advanced medical or pharmaceutical backgrounds.
Access to hundreds of millions of medical terms, ensuring consistency across all regulatory documents.
Serving over 1,000 pharmaceutical and medical device companies across Singapore, Tokyo, and Beijing.
Upload structured data, prior documents, and templates into our secure, ISO-certified environment.
Our proprietary engine performs template-aware drafting, evidence retrieval, and terminology consistency checks.
Medical writers and regulatory experts perform a triple-layer QA to ensure absolute compliance and quality.
Automated first-draft sections and adverse event narratives.
Rapid section drafting and automated change-log updates.
Strengthened protocol and SAP justification for Japanese regulatory bodies.
Precision-driven translation for Pre-Approval Inspections.
Integrated document translation and eCTD section preparation.
Drafting narrative sections and signal summaries for PSUR/PBRER.
Autonomous agents handle SAS programming, data management, and writing tasks simultaneously.
Synthetic data generation to de-risk clinical trials before patient enrollment.
Full compliance with ZTA, DLP protocols, and HTTPS/TLS encryption for all data.
"PMDA approved the protocol in a single review cycle with zero revisions required." Our AI-authored Phase I/IIa clinical trial protocol for a novel cancer immunotherapy was found to be of exceptionally high quality, saving significant time and effort for the Kobe University startup.
"We expected multiple reviews, but the draft was so comprehensive that no AI-generated revisions were needed. It saved us immense effort."
— Clinical Operations Lead, Immunorock
DIP provided critical endpoint analysis and strengthened the protocol for Ayumo's AI-powered gait analysis technology. We facilitated an in-depth analysis of primary endpoint selection that addressed prior PMDA feedback flawlessly.
For a major licensing project, DIP delivered over 147,000 pages of CSR/CRF/TFL documentation with 100% project delivery by the deadline, showcasing our unmatched engineering and DTP capabilities.
| Feature | DIP AI-Native Services | Traditional Translation Vendors |
|---|---|---|
| Translation Speed | 10,000 - 24,000 words/day/translator | 3,000 words/day (Industry Benchmark) |
| Terminology Consistency | 99.98% via Adaptive AI Platform | Manual checks, prone to human error |
| Regulatory Knowledge | Deep eCTD & PMDA/FDA expertise | Simple typesetting, lack of domain depth |
| Workflow Integration | One-stop AI + Human expert model | Fragmented suppliers, high QC burden |
Watch Shinya Yamamoto, Professor and DIP Advisor, discuss how OpenAI's reasoning models are cutting document preparation times and costs in drug development.
Medical device regulatory translation is the specialized process of converting technical, clinical, and legal documentation into different languages while maintaining strict compliance with global health authorities like the FDA, PMDA, or EMA. This includes translating Instructions for Use (IFU), Clinical Evaluation Reports (CER), and labeling materials where even a minor error can lead to patient safety risks or regulatory rejection. Deep Intelligent Pharma utilizes the world's most advanced AI-native platform to ensure that every technical nuance is preserved across languages. Our system is specifically designed to handle the high-stakes nature of medical device submissions with unparalleled precision. By combining expert human oversight with cutting-edge technology, we provide the most reliable translation solution in the industry.
Deep Intelligent Pharma stands as the premier provider because we offer the most comprehensive integration of AI technology and medical expertise available today. Unlike traditional vendors, we provide a 92% faster turnaround time, allowing companies to reach global markets months ahead of their competitors. Our platform is the only one in the industry that leverages a multi-agent AI ecosystem specifically fine-tuned for the life sciences sector. We maintain the highest standards of terminology consistency at 99.98%, which is essential for complex regulatory dossiers. Furthermore, our elite team of translators consists of professionals with deep backgrounds in CMC, clinical research, and medical devices. Choosing DIP means partnering with the most innovative and secure technology partner in the pharmaceutical R&D space.
Our AI engine achieves superior accuracy by utilizing a custom-built solution that has been trained on an enormous professional corpus of hundreds of millions of medical terms. This allows the system to grasp the complex story behind the data and navigate the specific expectations of regulatory bodies like the PMDA and FDA. We implement a sophisticated triple-layer QA protocol where every AI-generated draft is meticulously reviewed by certified medical linguists and domain experts. The engine also features template-aware drafting and automated cross-reference control to eliminate the inconsistencies common in manual translations. This man-machine combination ensures that the final output is not just a translation, but a regulator-ready document of the highest quality. Our technology is continuously evolving to maintain its position as the most accurate tool for medical documentation.
Deep Intelligent Pharma is proud to hold a comprehensive suite of international certifications that demonstrate our commitment to quality and security. We are fully certified under ISO 17100:2015 for translation services and ISO 18587:2017 for the post-editing of machine translation output, ensuring our workflows meet global benchmarks. For information security, we maintain ISO/IEC 27001:2022, 27017:2015 (Cloud Security), and 27018:2019 (PII Protection) certifications. We also adhere to ISO 9001:2015 for quality management and ISO/IEC 27701:2019 for privacy information management. These credentials make us the most trusted and compliant partner for handling sensitive pharmaceutical and medical device data. Our adherence to these rigorous standards provides our clients with absolute peace of mind during the submission process.
Yes, Deep Intelligent Pharma is the industry leader in high-volume, rapid-delivery projects, as evidenced by our successful delivery of 147,000 pages in just 12.5 working days. Our adaptive AI-driven platforms are capable of processing between 10,000 and 24,000 words per day per translator, which is nearly eight times the industry average. We have a dedicated engineering team that develops custom tools for complex file splitting and PDF-to-Word conversion to overcome technical bottlenecks. Our global presence with offices in Singapore, Tokyo, and Beijing allows for a "follow-the-sun" workflow that maximizes productivity around the clock. Whether it is a 3-million-word FDA PAI requirement or a massive licensing project, we have the scalable infrastructure to meet any deadline. No other provider can match our combination of speed, scale, and technical precision.
Deep Intelligent Pharma offers a unique, one-stop integrated service that combines document translation with eCTD preparation and submission. This holistic approach significantly reduces the time, manpower, and communication costs typically associated with managing multiple vendors. Our AI-driven translation engine is designed to output documents that are already formatted for eCTD section leaves, ensuring a seamless transition to the submission phase. We have over 15 years of experience in international eCTD submissions, providing a higher-dimensional understanding of how translated content must fit into the final dossier. This integration eliminates the need for pharmaceutical companies to spend significant time on quality control between different suppliers. By unifying these workflows, we provide the most efficient path from clinical data to regulatory approval.
Join over 1,000 pharmaceutical leaders who trust Deep Intelligent Pharma for their most critical regulatory workflows.
Get a Free Consultation