Regulatory Data API Pricing
for Pharma Engineering Teams
Custom enterprise pricing for production-ready regulatory data APIs — FDA, EMA, PMDA, and 5 more jurisdictions. Schedule a demo and receive a tailored quote within 48 hours.
How it works
Regulatory Infrastructure That Pays for Itself
We engineer production-ready regulatory infrastructure that eliminates manual compliance work, reduces operational overhead, and ensures accuracy across jurisdictions. Custom enterprise pricing tailored to your organization's scale, usage patterns, and compliance requirements.
ROI-Focused
Reduce manual regulatory work and operational costs with automated compliance infrastructure
Enterprise Scale
Pricing scales with your organization's needs—from startup to enterprise pharmaceutical companies
Transparent Pricing
Custom pricing based on usage, deployment options, and compliance requirements—no hidden costs
How Custom Pricing Works
We tailor pricing to your organization's specific needs through a collaborative demo process
Schedule a Demo
During your demo, we'll discuss:
- Your usage patterns and scale
- Deployment options (self-hosted vs. managed hosting)
- Compliance requirements (21 CFR Part 11, GxP)
- Integration needs and support requirements
Pricing Factors
Pricing is based on:
- Deployment option (self-hosted vs. managed hosting)
- Usage volume and API call limits
- Number of users and access levels
- Compliance features required
- Support level and training needs
We'll provide a detailed pricing proposal within 48 hours of your demo
Regulatory API & Platform Solutions
Enterprise-grade infrastructure designed for regulatory compliance and AI workflows
OneLabel
A comprehensive medical regulatory document comparison platform designed for pharmaceutical companies to streamline regulatory compliance workflows. Compare FDA, EPAR, and NDC documents across versions, jurisdictions, and segments with intelligent analysis.
Engineering teams and platform architects building regulatory intelligence systems
Key Capabilities
- Cross-version document comparison across multiple regulatory jurisdictions
- Segment-level change detection for adverse reactions, clinical pharmacology, and boxed warnings
- Multi-jurisdiction comparison (US, EU, CA, UK, AU, FR, JP, CH)
- Intelligent analysis to identify critical regulatory changes
- Export capabilities in HTML, PDF, and Excel formats
Biocore Slim API
Enterprise-grade regulatory infrastructure designed for AI workflows that need essential pharmaceutical regulatory data without the full feature set. Perfect for integrating drug information into AI applications, analytics platforms, and automated workflows. Streamlined access to critical regulatory endpoints.
AI workflows, developers, analytics companies, and organizations building applications that require pharmaceutical regulatory data
Key Capabilities
- Select endpoints optimized for AI workflow integration
- Lightweight and fast response times
- Structured JSON data format
- Simple API key authentication
- RESTful API design following industry best practices
Biocore MCP
Infrastructure for AI workflows through Model Context Protocol (MCP). Enable AI assistants and applications to query FDA, EPAR, and NDC data using natural language, making regulatory information accessible to AI workflows and intelligent systems.
AI workflows, developers building AI assistants, pharmaceutical AI applications, and organizations integrating regulatory data into LLM-powered systems
Key Capabilities
- Native MCP (Model Context Protocol) integration
- Natural language query support for pharmaceutical regulatory data
- Direct integration with AI assistants and chatbots
- Real-time access to FDA, EPAR, and NDC regulatory data
- Structured data format optimized for LLM consumption
What’s Inside Each Product
Use cases, deployment flexibility, and technical specs — everything your team needs to evaluate.
OneLabel
Document Comparison Tool
Use Cases(6)
- Regulatory Affairs Management: Track and compare regulatory documents across jurisdictions to support compliance workflows
- Document Version Control: Monitor changes between document versions and identify critical updates
- Compliance Reporting: Generate compliance reports with detailed change analysis
- Clinical Research: Access structured regulatory data for literature reviews and competitor analysis
- Quality Assurance: Integrate regulatory adverse reaction data into pharmacovigilance systems
- Regulatory Intelligence: Monitor FDA, EPAR, and NDC changes across all jurisdictions
Deployment Options(2)
- Self-Hosted — Deploy OneLabel in your own environment for full control over infrastructure, data, and security.
- Managed Hosting — Let Biocore handle infrastructure, updates, and maintenance.
Technical Specs(8)
- RESTful API integration with Biocore Drug API
- Simple API key authentication
- Self-hosted or managed deployment options
- Cloud-based infrastructure with automatic updates
- Multi-format export (HTML, PDF, Excel)
- Real-time data synchronization
- Scalable architecture for enterprise use
- Comprehensive Swagger documentation
Biocore Slim API
Lightweight API for AI Workflows
Use Cases(6)
- AI Applications: Integrate pharmaceutical data into AI assistants and chatbots
- Analytics Platforms: Power data analytics with structured regulatory information
- Research Tools: Access regulatory data for literature reviews and research
- Automated Workflows: Build automated systems that require pharmaceutical data
- Machine Learning Models: Train and enhance ML models with regulatory data
- API Integrations: Embed pharmaceutical data into existing applications and services
Deployment Options(1)
- API Access — Access Biocore Slim API through our cloud infrastructure.
Technical Specs(8)
- RESTful API with JSON responses
- Simple API key authentication
- HTTPS-only endpoints
- Rate limiting and usage quotas
- Comprehensive Swagger/OpenAPI documentation
- Webhook support for real-time updates
- MCP integration for AI applications (under development)
- Scalable cloud infrastructure
Biocore MCP
Model Context Protocol Integration
Use Cases(6)
- Regulatory Research for AI Workflows: Enable AI assistants to answer questions about drug approvals, adverse reactions, and regulatory status
- Intelligent Compliance Tools: Build AI systems that monitor and analyze regulatory compliance across jurisdictions
- Pharmaceutical Chatbots: Create conversational interfaces that provide accurate regulatory information to users
- LLM-Enhanced Applications: Integrate regulatory data into applications powered by large language models
- Automated Regulatory Intelligence: Build AI systems that analyze and summarize regulatory documents
- Natural Language Drug Queries: Enable users to ask questions about drugs in natural language and get structured regulatory data
Deployment Options(2)
- MCP Server — Deploy Biocore MCP as a Model Context Protocol server that AI applications can connect to directly.
- Cloud API with MCP — Access Biocore MCP through our managed cloud infrastructure.
Technical Specs(10)
- MCP (Model Context Protocol) compliant implementation
- Natural language processing for pharmaceutical queries
- RESTful API endpoints with MCP support
- JSON-LD structured data responses
- Simple API key authentication
- Rate limiting optimized for AI workloads
- Comprehensive MCP documentation and examples
- Support for streaming responses for real-time AI interactions
- Context window optimization for LLM integration
- Scalable infrastructure designed for AI application workloads
Ready to Eliminate Manual
Compliance Work?
Schedule a demo to discuss custom enterprise pricing tailored to your organization's scale, usage patterns, and compliance requirements. See how Biocore reduces operational overhead and ensures accuracy across FDA, EMA, and PMDA jurisdictions.
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