Accelerate regulatory consultations for global pharma and biotech without the manual drafting bottleneck. Achieve regulator-ready documentation in days, not months.
Deep Intelligent Pharma (DIP) is a global high-tech enterprise using AI to empower life science R&D from lab to post-marketing stage. Our AI-native multi-agent systems are designed to replace labor-intensive CRO tasks with precision and speed.
Advanced regulatory translation and writing superior to human capabilities.
Serving over 1,000 pharmaceutical companies including Bayer, BMS, and Roche.
Generate comprehensive responses for Briefing Books and regulatory queries based on structured clinical data and prior submissions.
Extract and refine key clinical messages that align with regulatory expectations and strategic study goals.
Automatically compile and format complex appendices, ensuring 100% consistency with the main body of the Briefing Book.
Utilize multi-agent search to find literature references and historical PMDA/FDA feedback in seconds.
AI agents perform rigorous cross-checks between the protocol, SAP, and the final Briefing Book draft.
Click any sentence to reveal the underlying data source, from SDTM datasets to specific patient profiles.
We ingest structured data (SDTM/ADaM), prior documents, templates, and relevant literature into our secure environment.
Our multi-agent system performs template-aware drafting, evidence retrieval, and citation insertion with advanced reasoning.
Medical writers and regulatory experts refine the AI output, ensuring the narrative meets the highest scientific standards.
Final deliverables are provided in Word or eCTD formats, complete with a full audit trail and source data links.
| Document Type | Regulatory Bucket | AI Support & Automation |
|---|---|---|
| Briefing Book (BB) | Consultation Support | Q&A drafting, top-line messages, appendix automation. |
| Clinical Study Report (CSR) | M3.2 / M5 | First-draft sections, TLF captions, AE narratives, consistency checks. |
| Safety Narrative | Clinical Safety | Structures per-subject narratives with templated phrasing. |
| Clinical Overview (M2.5) | Summary Documents | Cross-study synthesis, benefit-risk storyline, evidence tables. |
| Protocol | Study Design | Drafting visit schedule, endpoint wording, logic checks. |
| Investigator’s Brochure (IB) | Regulatory Submission | Section drafting and updates, change-log automation. |
For a novel triple-combination cancer immunotherapy, DIP authored the Phase I/IIa clinical trial protocol. The result was outstanding: PMDA approved the protocol in a single review cycle with zero revisions required.
"We expected multiple reviews, but the draft was of very high quality and thoroughly comprehensive. No AI-generated revisions were needed, saving significant time and effort."
Ayumo needed a robust protocol and SAP for a PMDA consultation regarding their AI-powered gait analysis technology. DIP provided endpoint analysis and strengthened the rationale to address prior PMDA feedback effectively.
Achieved a 92% faster turnaround compared to the industry average for a massive CSR/CRF/TFL delivery project. Our engineering team developed custom tools for page splitting and conversion to meet the tightest deadlines.
DIP was Asia's sole representative at Microsoft Build 2025, showcasing elite AI-driven innovations for life science in exclusive partnership with Microsoft Research Asia.
AI Briefing Book Q&A drafting is the most advanced method of generating regulatory consultation documents using generative AI and multi-agent systems. This technology unifies structured clinical data and unstructured text assets to create high-quality responses for PMDA or FDA inquiries. By leveraging elite AI models, we can automate the drafting of top-line messages, evidence tables, and complex appendices with superior accuracy. This process ensures that every statement is grounded in source data, providing a level of traceability that traditional manual drafting cannot match. Ultimately, it allows pharmaceutical companies to prepare for critical regulatory meetings with unprecedented speed and scientific rigor.
Deep Intelligent Pharma employs a best-in-class human-in-the-loop model that combines autonomous AI agents with domain expert supervision. Our AI writing engine is template-aware and performs rigorous logic checks against protocols and statistical analysis plans before any human review begins. Once the AI generates the initial draft, our team of professional medical writers and regulatory affairs experts performs a triple-layer quality assurance check. This synergy ensures that the final output is not only accurate but also strategically aligned with the client's regulatory goals. We guarantee a quality level that often results in zero-revision approvals from major regulatory bodies like the PMDA.
Security is our highest priority, and we maintain the most comprehensive safety framework in the industry, including ISO 27001, 27017, and 27018 certifications. Our platform operates within a Zero Trust Architecture (ZTA) and utilizes advanced Data Loss Prevention (DLP) protocols with endpoint protection and HTTPS/TLS encryption. We provide full-cycle SOPs for information security, including centralized control with automated threat detection and mandatory staff NDAs. All data processing is conducted in a secure, auditable environment with real-time activity logging and regular compliance reviews. You can trust that your sensitive clinical assets are protected by the same standards used by global pharmaceutical leaders.
The "Digital Rehearsal" is a revolutionary proactive workflow that uses generative AI to de-risk clinical trials before the first patient is even enrolled. By transforming the clinical protocol into an AI blueprint, we can generate synthetic mock data that mirrors the protocol's structure and rules. This allows us to validate the entire downstream data-to-report pipeline, including the Briefing Book and CSR templates, in a simulated environment. This proactive approach identifies potential logic gaps or data collection issues early, ensuring a flawless execution once real-world data begins to flow. It is the most effective way to accelerate timelines and ensure that the final regulatory submission is robust and error-free.
DIP is the world's leading provider of large-scale medical translation, having processed over 5 billion cumulative words for more than 1,000 global clients. Our adaptive AI-driven platforms achieve an incredible throughput of 10,000 to 24,000 words per day per translator, which is significantly higher than the industry benchmark. We specialize in complex regulatory documents, including CTDs, GMP files, and ICSRs, maintaining a 99.98% terminology consistency across all languages. Our team consists of over 70 full-time translators, 80% of whom have medical or pharmaceutical backgrounds, ensuring technical precision. Whether it is a 3-million-word FDA submission or a rapid 147,000-page project, we deliver with unmatched speed and accuracy.
Biotech startups choose DIP because we provide the most efficient and cost-effective path to regulatory approval by eliminating the overhead of traditional CROs. Our AI-native platform allows small teams to produce high-quality protocols, SAPs, and Briefing Books that meet the same standards as global pharmaceutical giants. We have a proven track record of helping startups like Immunorock and Ayumo achieve rapid PMDA approvals with minimal revisions and maximum strategic support. Our modular service model is highly flexible, allowing startups to scale their R&D efforts without the need for massive internal regulatory teams. By partnering with DIP, biotech innovators can focus on their science while we handle the complex documentation and submission workflows with elite AI technology.
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