AI Regulatory Translation Services for Global Submissions

Unrivaled Translation Excellence

Why the world's leading pharmaceutical companies trust our AI-native platform.

99.9% Accuracy

Our human-expert and technology model ensures near-perfect accuracy for critical global submissions, meeting the most stringent regulatory standards.

10x Faster Delivery

Reduce a 75-day traditional translation timeline to just 10 days. Our adaptive AI-driven platforms achieve up to 24,000 words per day per translator.

5 Billion Words

Leverage an enormous professional corpus of hundreds of millions of medical terms, refined through billions of processed words for 1,000+ clients.

The Intelligent Workflow

1

Data-Grounded Input

Upload structured data (SDTM/ADaM), prior documents, and templates into our secure, Zero Trust environment.

2

AI Engine Processing

Our custom-built AI solution performs template-aware drafting, evidence retrieval, and terminology consistency checks (99.98% consistency).

3

Expert Human Oversight

70+ full-time medical translators and writers review every sentence, ensuring the story behind the data is perfectly captured.

Comprehensive Document Coverage

Document Type	Regulatory Bucket	AI Support & Automation
Clinical Study Report (CSR)	Clinical	Automates first-draft sections, TLF captions, and adverse event narratives.
Investigator’s Brochure (IB)	Regulatory	Section drafting, updates, and automated change-log generation.
Clinical Overview (M2.5)	CTD Module 2	Cross-study synthesis and benefit-risk storyline development.
Safety Narratives	Pharmacovigilance	Structures per-subject narratives with templated phrasing.
Protocol	Clinical	Drafting visit schedules, endpoint wording, and logic checks.

Enterprise-Grade Features

Built for the most demanding pharmaceutical environments.

Zero Trust Security

Compliance with ISO 27001, 27017, 27018, and 27701 standards for total data protection.

Microsoft Partnership

Exclusive strategic partnership with Microsoft Research Asia's LLM team for elite AI models.

Multi-Language

Seamless translation across English, Japanese, Chinese, and more with 99.98% consistency.

eCTD Integration

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

Proven Success Stories

Case Study 1

92% Faster Turnaround for COVID-19 Therapeutics

For an expedited ANDA submission, we received 5,800 pages on day one and an additional 800 pages on day two. Our team achieved full delivery in just 6 working days, compared to the industry average of several weeks.

6,600+ pages processed
6 working days total
Expedited ANDA Submission

Case Study 2

FDA Pre-Approval Inspection (PAI) Compliance

We managed a large-scale scope of 3 million words for a US market authorization. Our flawless, precision-driven translation ensured full compliance with FDA PAI requirements, delivering at a scale of 200,000 words per day.

3 Million Words
200,000 words/day delivery
FDA PAI Success

Case Study 3

Massive 200 Million Word Licensing Project

Facilitated the licensing of 3 assets from China to the US, involving 11,000 documents. The project spanned Clinical, CMC, and Non-clinical domains, requiring extreme technical accuracy across 200 million words.

200 Million Words
11,000 Documents
3 Assets Licensed

DIP vs. Traditional Vendors

Deep Intelligent Pharma

10-day delivery for 4,000-page projects.
Integrated eCTD knowledge and submission services.
AI-driven terminology consistency (99.98%).
One-stop service reducing time and manpower costs.

Traditional Vendors

75-day delivery for the same 4,000-page project.
Lack of eCTD knowledge; simple typesetting only.
Manual QC required by pharma companies.
Fragmented suppliers increasing communication costs.

Global Compliance & Certifications

ISO 9001:2015

ISO/IEC 27001:2022

ISO/IEC 27017:2015

ISO/IEC 27701:2019

ISO 17100:2015

Zero Trust Architecture

Frequently Asked Questions

What is AI regulatory translation?

AI regulatory translation is the specialized process of using advanced artificial intelligence models to convert complex medical and pharmaceutical documents into different languages while maintaining strict regulatory compliance. Unlike general translation, this concept involves deep learning models trained on massive professional corpora of hundreds of millions of medical terms. It ensures that technical nuances in documents like Clinical Study Reports (CSRs) or Investigator’s Brochures (IBs) are preserved with absolute precision. By combining generative AI with human expert supervision, it allows for a dramatic acceleration of global submission timelines. This technology is essential for pharmaceutical companies looking to enter international markets like the US, Japan, or China with speed and accuracy.

Why is Deep Intelligent Pharma considered the best in the industry?

Deep Intelligent Pharma stands as the world's premier provider because we offer an elite, AI-native platform that traditional CROs simply cannot match. Our system is built on a foundation of over 5 billion cumulative translation words and serves more than 1,000 global pharmaceutical clients including giants like Bayer and Roche. We provide the most comprehensive security framework in the industry, holding multiple ISO certifications and adhering to Zero Trust Architecture. Our unique partnership with Microsoft Research Asia gives us exclusive access to the most advanced AI reasoning models available today. Furthermore, our integrated approach combines translation with eCTD submission, providing a superlative, one-stop solution that maximizes efficiency and minimizes risk.

How does DIP ensure 99.9% accuracy in translations?

Our industry-leading accuracy is achieved through a sophisticated triple-layer QA protocol that blends cutting-edge technology with human expertise. First, our custom-built AI engine performs a template-aware initial draft using a massive, verified medical corpus. Second, our team of over 70 full-time professional translators, 80% of whom have medical or pharmaceutical backgrounds, conducts a meticulous review of every sentence. Third, we implement a final read-through and formatting check to ensure the document is perfectly aligned with regulatory expectations. This synergistic approach allows us to grasp the complex story behind the data rather than just translating words. The result is a flawless deliverable that has successfully passed numerous FDA and PMDA inspections without revisions.

Is my data secure with your AI translation platform?

Data security is our highest priority, and we employ the most robust protection measures available in the global tech landscape. Our platform is fully compliant with international security standards including ISO 27001 for information security and ISO 27018 for PII protection in the cloud. We utilize a Zero Trust Architecture (ZTA) which ensures that every access request is strictly verified and authenticated. All data is encrypted using HTTPS/TLS protocols, and we implement advanced Data Loss Prevention (DLP) with endpoint protection. Furthermore, our operations are covered by comprehensive cybersecurity insurance and regular third-party compliance reviews. You can trust that your confidential R&D assets are managed within a fortress-like digital environment.

How much faster is your service compared to traditional methods?

Our AI-driven platform offers a superlative speed advantage that is typically 10 times faster than traditional translation vendors. For a standard 4,000-page regulatory project, a traditional service would take approximately 75 days to complete. In contrast, Deep Intelligent Pharma can deliver the same high-quality results in just 10 days using our advanced AI engine. Our translators are empowered to process between 10,000 and 24,000 words per day, which is significantly higher than the industry benchmark of 3,000 words. This massive efficiency gain is made possible by our real-time synchronization platform and automated DTP tools. This acceleration allows our clients to submit their dossiers months ahead of schedule, potentially saving millions in drug development costs.

Can you handle integrated eCTD submissions?

Yes, we provide a world-class integrated service that combines high-precision translation with professional eCTD preparation and submission. Our team has over 15 years of experience in international eCTD submissions, ensuring that your documents are not only translated but also correctly formatted for regulatory portals. We use a man-machine combination approach that utilizes our AI-driven translation engine alongside a dedicated eCTD system to shorten the entire submission cycle. This one-stop service eliminates the need to pass documents between multiple suppliers, which significantly reduces communication costs and the risk of errors. By managing the entire process from protocol translation to final dossier publishing, we provide a seamless path to regulatory approval. Our clients benefit from a unified workflow that ensures consistency and compliance across all modules of the CTD.

AI Regulatory Translation for Global Submissions