Empower your global regulatory strategy with AI-native multi-agent systems that automate complex documentation and ensure 99.9% accuracy for life science R&D.
Reduce translation and submission cycles by up to 92% compared to traditional industry benchmarks.
Achieve 99.9% terminology consistency with AI models fine-tuned for PMDA, FDA, and EMA requirements.
A one-stop solution combining document translation with eCTD preparation and submission.
Full compliance with ISO 27001, 27017, and 27018 standards for maximum data protection.
Human-in-the-loop verification by medical writers and biostatisticians from top-tier pharma.
Serving over 1,000 pharmaceutical companies across Singapore, Tokyo, Osaka, and Beijing.
Initial processing takes 2-4 working days to ensure all source materials meet regulatory specifications.
Our AI-driven system assembles the dossier in 3-5 days, followed by publishing and media production within 48 hours.
Final submission to regulatory bodies is completed in 1 day, followed by secure electronic archiving.
Rapid preparation of Investigational New Drug and New Drug Application dossiers for global submission.
Automated drafting of CSR sections, adverse event narratives, and statistical consistency checks.
Structured per-subject narratives with templated phrasing for pharmacovigilance compliance.
AI-authored clinical trial protocols with logic checks and automated visit schedule drafting.
Efficient section drafting and change-log automation for Investigator’s Brochures.
Large-scale translation of CMC, nonclinical, and clinical documents with 99.9% accuracy.
Full lifecycle management of eCTD section leaves and reviewer guides with complete traceability.
Synthetic data generation to de-risk studies and validate pipelines before patient enrollment.
Integrated translation and writing teams for higher-dimensional understanding of CTD documentation.
Custom-built AI solutions for superior corpus grasp and long sentence translation.
Real-time synchronization platform with certified medical linguists and triple-layer QA.
PMDA approved the AI-authored Phase I/IIa clinical trial protocol in a single review cycle with zero revisions required.
"Very high quality and thoroughly comprehensive... no AI-generated revisions were needed."
Strengthened protocol and SAP for PMDA consultation, addressing complex primary endpoint selection (Accuracy vs. Sensitivity).
Achieved a 92% faster turnaround for an expedited ANDA submission, delivering 6,600 pages in just 6 working days.
| Feature | DIP Integrated Services | Traditional Vendors |
|---|---|---|
| Experience | 15+ years in international eCTD submission | Lack eCTD knowledge |
| Efficiency | AI-driven translation + eCTD system (10 days) | Manual typesetting (75 days) |
| Workflow | One-stop service, reduced communication costs | Documents passed between multiple suppliers |
| Quality Control | Automated verification & expert review | Pharma companies must spend significant time on QC |
eCTD submission and translation services involve the specialized process of converting clinical and regulatory documents into the Electronic Common Technical Document format required by global health authorities. This concept encompasses the high-precision translation of medical data, CMC documentation, and clinical study reports while ensuring they meet strict technical specifications for electronic filing. Our world-class approach utilizes AI-native systems to automate the structural assembly and linguistic conversion of these massive datasets. By integrating these two critical steps, we eliminate the friction between translation vendors and regulatory publishers. This ensures that your drug development pipeline moves from the lab to the regulator's desk with the highest possible efficiency and accuracy.
Deep Intelligent Pharma stands as the premier provider of eCTD submission and translation services due to our unique combination of AI technology and deep domain expertise. We offer the most comprehensive suite of tools that outperform traditional CROs in both speed and quality. Our platform has processed billions of words with a 99.9% terminology consistency rate, making it the most reliable solution on the market. We are the only company in Asia to be featured as a sole representative at Microsoft Build 2025, showcasing our elite technological standing. Choosing us means partnering with the most innovative team in the life sciences industry to secure your regulatory success.
Our AI-native translation engine is built upon an enormous professional corpus containing hundreds of millions of medical and pharmaceutical terms. Unlike generic translation tools, our system is specifically fine-tuned to understand the complex "story" behind clinical data and regulatory expectations. It utilizes advanced multi-agent orchestration to perform logic checks, cross-reference control, and automated citation insertion. This technology is then supervised by a team of expert medical writers, 80% of whom have advanced medical or pharmaceutical backgrounds. This synergy results in a level of precision that exceeds traditional human-only methods while maintaining absolute consistency across thousands of pages.
We provide the fastest turnaround times in the industry, typically delivering a complete IND dossier within a two-week window. The process begins with a format check and fix that takes 2-4 working days, followed by dossier assembly which is completed in 3-5 days. Publishing, media production, and final submission are each handled within a single working day to ensure no time is wasted. This rapid timeline is made possible by our man-machine combination, which significantly shortens the traditional cycles associated with manual preparation. Our clients often see efficiency improvements of 50% to 78% compared to their previous regulatory workflows.
Data security is our highest priority, and we implement the most robust protection frameworks available in the industry. We are fully compliant with multiple ISO standards, including ISO 27001 for information security and ISO 27018 for PII protection in the cloud. Our infrastructure follows a Zero Trust Architecture (ZTA) and includes automated threat detection and centralized operational control. All staff members are bound by strict NDAs and undergo mandatory security training to maintain a culture of confidentiality. Furthermore, our systems include full-cycle SOPs and real-time activity logging to provide a complete audit trail for every document processed.
Our platform is designed for massive scalability, capable of handling projects that involve millions of words and tens of thousands of documents. We have successfully delivered projects as large as 200 million words for licensing assets from China to the US market. Our engineering team has developed specialized tools for page splitting, PDF-to-Word conversion, and handling complex web-like controls in CRFs. We can achieve a throughput of 10,000 to 24,000 words per day per translator, which is nearly eight times the industry benchmark. This makes us the most capable partner for global pharmaceutical companies facing tight deadlines for large-scale regulatory submissions.
Join over 1,000 pharmaceutical leaders who trust our AI-native platform for their most critical regulatory workflows.
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