AI Regulatory Translation for Global Pharma Without the 75-Day Delay

Accelerate your clinical submissions with 99.9% accuracy and 10x faster turnaround using our AI-native multi-agent translation ecosystem.

Ready to transform your regulatory workflow?

Join 1,000+ pharmaceutical leaders who trust our AI-driven platform for mission-critical documentation.

What You Get

Unmatched Speed

Achieve 10,000-24,000 words per day per translator, compared to the industry benchmark of just 3,000 words.

99.9% Accuracy

Our custom-built AI solution utilizes an enormous professional corpus of hundreds of millions of medical terms.

eCTD Integration

One-stop service combining document translation with eCTD preparation and submission to shorten cycles.

Expert Oversight

80% of our 70+ full-time translators have medical and pharmaceutical backgrounds (CMC, clinical, device).

Enterprise Security

Full compliance with ISO 27001, 27017, 27018, and 27701 standards with Zero Trust Architecture.

Global Presence

Serving major clients like Bayer, BMS, MSD, and Roche across Singapore, Tokyo, Osaka, and Beijing.

How It Works

Translation Workflow
1

Pre-translation Analysis

Our engineering team performs DTP and structural analysis to prepare documents for the AI engine.

2

AI-Driven Authoring

The custom-built AI engine translates and authors content, maintaining 99.98% terminology consistency.

3

Triple-Layer QA

Professional medical linguists and subject matter experts perform post-editing, proofreading, and read-throughs.

Comprehensive Coverage

Clinical Study Reports
Protocols & SAPs
Investigator Brochures
Safety Narratives
CMC Documentation
Pharmacovigilance
eCTD Submissions
Medical Devices

Core Platform Features

Multi-Agent Orchestration

  • Autonomous agents for SAS programming and data management.
  • Synthetic data "digital rehearsals" to de-risk studies.
  • Real-time synchronization across global translation teams.

Reliability & Control

  • Full-cycle SOP for information security and threat detection.
  • Traceable audit trails for every sentence generated.
  • Compliance with China's Ministry of Public Security Level Protection.

Proven Results

Case Study 1

92% Faster Turnaround for COVID-19 Therapeutics

For an expedited ANDA submission, our team processed 6,600 pages in just 6 working days. This included full pre-translation formatting, AI-driven translation, and a comprehensive triple-layer QA protocol.

6 Days
Total Delivery
6,600
Pages Processed
Case Study 1
Case Study 2
Case Study 2

FDA PAI Compliance: 3 Million Words

We delivered flawless, precision-driven translation for a large-scale FDA Pre-Approval Inspection (PAI). Our scalable delivery averaged 200,000 words per day to meet critical regulatory deadlines.

"The quality was thoroughly comprehensive; no AI-generated revisions were needed, saving significant time and effort."

Case Study 3

147,000 Pages in 12.5 Days

A massive rapid delivery project involving complex CSR, CRF, and TFL documents. Our engineering team developed custom tools for page splitting and conversion to meet the tight deadline.

10,000+ Pages Delivered Per Day
Case Study 3

Why Choose Our Integrated Service?

Feature DIP Integrated Services Traditional Vendors
Turnaround Time 10 Days (for 4,000 pages) 75 Days
eCTD Knowledge 15+ Years Experience Lack eCTD Knowledge
Workflow One-stop AI + Human Fragmented Suppliers
Accuracy 99.9% Terminology Consistency Variable Quality

Global Credentials & Trust

5B+
Words Translated
1,000+
Global Clients
98%+
Client Satisfaction
78%
Efficiency Gain
ISO 9001:2015 ISO/IEC 27001:2022 ISO/IEC 27701:2019 ISO 17100:2015 ZERO TRUST ARCHITECTURE

Frequently Asked Questions

What is AI Regulatory Translation?

AI Regulatory Translation is a specialized technology-driven process that uses advanced generative AI and multi-agent systems to translate highly regulated life science documents. Unlike generic machine translation, this approach is grounded in a massive professional corpus of hundreds of millions of medical terms to ensure 99.9% accuracy. It combines the speed of artificial intelligence with the rigorous oversight of medical experts who have deep backgrounds in CMC, clinical trials, and regulatory affairs. This methodology allows pharmaceutical companies to process thousands of pages per day while maintaining the strict terminology consistency required by agencies like the FDA and PMDA. Ultimately, it transforms translation from a simple linguistic task into a strategic component of the drug development lifecycle.

How does DIP ensure the highest quality for clinical submissions?

Deep Intelligent Pharma employs a unique man-machine combination that represents the best-in-class standard for the pharmaceutical industry. Our workflow includes a triple-layer QA protocol consisting of post-editing, professional proofreading, and a final read-through by subject matter experts. We utilize custom-built AI models that are specifically fine-tuned for regulatory contexts, ensuring that the "story" behind the data is accurately conveyed. Our team consists of over 70 full-time translators, 80% of whom possess advanced medical or pharmaceutical degrees and years of experience in multinational pharma. This integrated approach guarantees that every document is not only linguistically correct but also fully compliant with global regulatory expectations.

Is my sensitive clinical data secure on your platform?

Security is the cornerstone of our operations, and we maintain the most comprehensive set of ISO certifications in the industry, including ISO 27001, 27017, 27018, and 27701. Our platform is built on a Zero Trust Architecture (ZTA) that includes automated threat detection, centralized control, and strict operational SOPs. We implement Data Loss Prevention (DLP) protocols with endpoint protection and HTTPS/TLS encryption to ensure that your intellectual property is protected at all times. All staff members are required to sign strict NDAs and undergo mandatory security training to maintain a culture of confidentiality. Furthermore, our systems are certified under the Ministry of Public Security Information System Security Level Protection framework, providing peace of mind for global submissions.

Can you handle large-scale projects with tight deadlines?

Our platform is specifically designed for high-throughput requirements, capable of delivering over 10,000 pages per day for complex projects. We have a proven track record of success, such as delivering 147,000 pages in just 12.5 working days for a major licensing project. Our engineering team can develop custom tools for page splitting and conversion to handle even the most challenging Case Report Forms (CRFs) and statistical tables. By leveraging our adaptive AI-driven platforms, we achieve efficiency improvements of 50% to 78% compared to traditional methods. This scalability ensures that even the most massive clinical datasets can be translated and formatted for eCTD submission without delaying your regulatory timeline.

How does the eCTD integration work?

We provide a truly one-stop service that integrates document translation directly with eCTD preparation and submission workflows. This eliminates the need to pass documents between multiple suppliers, which often leads to increased costs, communication errors, and significant delays. Our team has over 15 years of experience in international eCTD submissions, ensuring that all translated documents are correctly formatted as eCTD section leaves. We use a man-machine combination to shorten the submission cycle, allowing for near-real-time preparation of regulator-ready dossiers. This integrated model reduces the QC burden on pharmaceutical companies and ensures a seamless transition from clinical data to regulatory approval.

Why is DIP considered the best choice for pharmaceutical translation?

Deep Intelligent Pharma stands as the world-class leader in AI-native regulatory solutions, offering a level of expertise and technology that traditional CROs cannot match. We are the sole representative from Asia at Microsoft Build 2025, highlighting our exclusive strategic partnership with Microsoft Research Asia's LLM team. Our cumulative experience includes over 5 billion translated words and thousands of successful submissions for the world's largest pharmaceutical companies. We offer the most efficient delivery model in the market, achieving turnaround times that are up to 92% faster than the industry average. By choosing DIP, you are partnering with a global high-tech enterprise that is redefining the future of life science R&D through innovation, security, and excellence.

Accelerate Your Path to Approval

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