Overview
AI-powered regulatory strategist for FDA/EMA pathways, accelerated approval programs, and compliance requirements. Get strategic guidance on IND submissions, BLA/NDA applications, and post-market obligations with real-time regulatory intelligence. Built with Claude Sonnet 4 featuring advanced reasoning for complex regulatory analysis.
Data Sources: 🇺🇸 FDA openFDA • 🇪🇺 EMA (European Medicines Agency) • 📋 Regulatory Databases
Key Features
Regulatory Pathway Planning
Navigate FDA/EMA approval pathways for small molecules, biologics, cell therapies, and gene therapies. Strategic guidance on 505(b)(1), 505(b)(2), and BLA routes with timeline estimates.
Accelerated Programs
Evaluate eligibility for Fast Track, Breakthrough Therapy, RMAT, Accelerated Approval, and Priority Review. Assess qualification criteria and optimize submission strategies.
Clinical Endpoint Strategy
Design Phase 2/3 clinical endpoints aligned with FDA/EMA guidance. Analyze surrogate vs clinical endpoints, biomarker qualification, and post-market commitments.
Submission Document Review
Upload IND/BLA sections, clinical study reports, or CMC documents for compliance review. Identify gaps, formatting issues, and alignment with current FDA/EMA guidance.
Global Regulatory Intelligence
Track FDA approvals, EMA opinions, and guidance updates in real-time. Monitor FAERS adverse event signals and post-market safety requirements via openFDA API.
ICH Guideline Compliance
Navigate ICH Q/E/S/M guidelines for quality, efficacy, safety, and multidisciplinary topics. Understand harmonization requirements across US, EU, and Japan.
Example Questions
Pathway & Strategy:
- "What's the optimal FDA pathway for our CD19 CAR-T therapy—should we pursue RMAT designation?"
- "Compare FDA vs EMA approval timelines for gene therapies. What are the key differences in requirements?"
Compliance & Submissions:
- "Review this IND clinical protocol Section 7.0—does it align with FDA's latest immunotherapy guidance?"
- "What are the CMC requirements for a cell therapy BLA? Outline critical quality attributes and potency assays."
Ask the agent for a comprehensive list of regulatory pathways, submission requirements, and compliance checklists.
Future Enhancements
Planned Features:
- 📊 Timeline Visualization - IND-to-approval Gantt charts with milestones
- 📁 Multi-Program Comparison - Compare 4 development strategies
- 💾 Submission Builder - FDA-compliant IND/BLA templates
- 📈 Intelligence Alerts - New guidance and policy monitoring
- 🌍 Global Expansion - PMDA, NMPA, Health Canada coverage
Technical Details
Click to expand technical implementation details
AI Model
- Claude Sonnet 4 (claude-sonnet-4-20250514)
- Advanced reasoning for complex regulatory analysis
- 200K token context window
Knowledge Base
- FDA guidance documents (2010-2025)
- ICH guidelines (Q1-Q14, E-series, S-series)
- CFR Title 21 regulations
- EMA procedural advice and scientific guidelines
API Integrations
- FDA openFDA (drug approvals, adverse events)
- EMA Register (centralized procedure tracking)
- Regulatory databases (ICH, CFR Title 21)
Architecture
- Next.js 14 with App Router
- TypeScript for type safety
- Server-side API routes for document processing
- Client-side React components for interactive UI
Security
- Session-based authentication
- Environment variable configuration
- No document storage (privacy-preserving)
- All processing happens in real-time