Regulatory Strategy Agent
đ¤Claude Sonnet 4Get expert regulatory guidance on FDA/EMA pathways, accelerated approval programs, CMC requirements, and strategic regulatory planning for biotech products.
Demo Mode: Pre-recorded conversations. File uploads simulated.
Try Demo Mode
Click the button below to see a pre-recorded regulatory analysis. No API costs.
Technical Specifications
AI model, API connections, and data sources powering this agent
AI Model
Superior reasoning for complex regulatory pathways, CMC requirements, and strategic planning
API Connections
Real-time access to FDA guidance documents, approval letters, and regulatory precedents
Extract regulatory requirements and guidance from FDA/EMA documents
Data Sources
FDA guidance documents, drug approvals, breakthrough designations, and regulatory precedents
European regulatory requirements, CHMP opinions, and centralized approvals
IND submissions, regulatory correspondence, and clinical development plans
MCP Server (Enhanced Features)
About These Specifications
This agent uses a multi-model architecture where each agent is powered by the AI model best suited for its task. Real-time data sources provide up-to-date information, while MCP servers enable advanced data retrieval when enabled.
Behind the Scenes
Mode
Demo
Demo Mode
Pre-recorded regulatory pathway analyses demonstrating capabilities without API costs
Specialization
Regulatory Strategy
Regulatory Intelligence
FDA/EMA pathways, IND/BLA strategy, CMC requirements, accelerated approval, breakthrough therapy designation, and clinical endpoint selection
Capabilities
Strategic Planning
Pathway Optimization
Complex regulatory reasoning, policy interpretation, risk mitigation, accelerated approval strategies, and full guidance document analysis
Cost
Free
Zero Cost
Demo mode is completely free with pre-recorded regulatory analyses