Accelerate FDA responses and regulatory submission by 50%
Empower your team with RegAI—the conversational AI co-pilot that transforms complex drug labels and compliance documents into instant, hallucination-free insights.
Is the regulatory bottleneck slowing your innovation?
Regulatory affairs professionals face a major challenge: data volume is rising, yet management tools remain largely manual.
Cumbersome manual research
Hours spent reviewing contracts, NDAs, and FDA labels line-by-line.
Error-Prone processes
Manual checks lead to oversights, compliance gaps, and potential fines.
Inefficient timelines
Health Authority query responses take hours to draft, delaying critical submissions.
Meet RegAI: Your AI Co-Pilot for regulatory excellence
An AI that searches and understands the context of your query. It integrates LLMs and RAG to enable users to pose complex questions in natural language and receive accurate, sourced answers within seconds.
Key Capabilities:
- Conversational FDA label querying: Ask, “What are the dosing adjustments for renal impairment?” and get an instant answer derived specifically from the label.
- Automated document analysis: Scan NDAs and compliance docs in minutes, flagging non-compliant clauses against GDPR and EU AI Acts.
- One-Click source verification: Unlike standard chatbots, RegAI eliminates hallucinations by providing in-line citations and clickable hyperlinks to the source document.
Proven efficiency gains
Based on internal POC testing with 50+ compliance documents and 15 FDA labels.
50%
reduction in Health Authority query response preparation time
30-40%
increase in team productivity
30%
fewer compliance gaps via AI-driven analysis
100%
traceability with direct source PDF links
Key features & benefits
Time savings
- Reduces Health Authority query responses
- Accelerates submission preparation
Compliance & accuracy
- Hallucination-free insights with in-line citations
- Clickable hyperlinks to sources
Advanced capabilities
- Natural language search on FDA/EMA labels
- Query & Response Drafting for safety signals
- Downstream analytics and audit readiness
Case study: transforming regulatory compliance with RegAI
Profile: Andrew, Senior Regulatory Compliance Officer
Andrew serves as a Senior Regulatory Compliance Officer at a mid-sized tech firm specializing in data-driven solutions. He is responsible for safeguarding the organization’s operations against evolving legal landscapes. His core duties include:
- Overseeing Compliance Initiatives
- Reviewing Legal Documentation
- Enforcing Adherence to Key Standards – GDPR , HIPAA , EU AI Act
Challenges Before RegAI: A Labor-Intensive Status Quo Before adopting RegAI, Andrew’s workflow was bogged down by manual, fragmented processes that drained time and resources.
Key challenges included:
Challenge & Impact
- Manual Reviews Hours per document; delays audits.
- Tedious Research Days scouring databases for regs.
- Error Risks Human oversights invite fines.
- Scalability Limits Overloaded by growing workloads.
After RegAI: AI-Powered Agility
RegAI automates the grind, turning hours into minutes:
| Benefit | How It Works | Gains |
|---|---|---|
| Auto-Analysis | Scans documents in minutes; flags issues and suggests GDPR/EU AI Act fixes. | 30% faster reviews. |
| Instant Insights | Pulls rules from source documents with summaries and citations. | Slashes research time by 30%. |
| Error Reduction | AI cross-checks outputs for higher precision. | Near-zero oversights. |
| Scalable Workflow | Handles multiple documents through centralized dashboards. | 30–40% productivity boost. |
Enterprise-Grade architecture you can trust
RegAI is built on a secure, scalable enterprise stack.
RAG layer
(Retrieval-Augmented Generation): Ensures answers are grounded in your data rather than generated from thin air.
Multimodal analysis
Capable of processing text, images, and audio queries.
Secure infrastructure
Powered by AWS S3, Milvus/Weaviate vector databases, and React/FastAPI.
Data privacy
Secure document upload (up to 30MB/session) with strict access controls.
Competitive edge
| Feature | BenevolentAI | IQVIA | OpenAI (Partnerships) | Excelra RegAI |
|---|---|---|---|---|
| FDA Label Querying | Limited; focused on discovery | NLP extraction & comparisons | AI tools like cderGPT | One-click source access; 40–50% faster cycles |
| Key Offerings | Drug safety reports | Label comparisons & insights | Risk assessments | Automated compliance analytics; hallucination-free |
| Accuracy & Citations | Risk of hallucinations | Proprietary data dependency | Potential accuracy issues | In-line citations & hyperlinks for credibility |
Your path to regulatory automation
Discovery Workshop
Identify challenges where GenAI unlocks value.
Use Case + Data Assessment
Evaluate data readiness and integration needs.
Pilot
Validate feasibility and impact with MVP.
Deployment
Integrate into workflows for enterprise-wide value.
Knowledge hub
Filter
Ready to Innovate, Comply, and Succeed?
Stop wasting hundreds of hours on manual research. Empower your team with RegAI today.
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