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API Documentation

Enterprise-grade API for pharmaceutical companies and AI workflows. Integrate regulatory compliance data across FDA, EPAR, and NDC jurisdictions.

Getting Started

Welcome to the Biocore API documentation. Our enterprise-grade regulatory infrastructure provides pharmaceutical companies and AI workflows with access to regulatory data from FDA, EPAR, and NDC across 8 major pharmaceutical markets. Streamline regulatory compliance, reduce manual work, and ensure accuracy with our production-ready API infrastructure.

Our products include Biocore Slim API (lightweight API for AI workflows) and Biocore MCP (Model Context Protocol integration). Both provide comprehensive endpoints for regulatory data access optimized for integration into pharmaceutical applications and AI workflows.

Quick Start

  1. Schedule a demo to discuss your integration requirements
  2. Receive your API credentials and access documentation
  3. Make your first API call using the examples below
  4. Explore comprehensive endpoints for regulatory data across all jurisdictions

Authentication

All API requests require authentication using an API key. Include your API key in the request header for every API call. Our enterprise-grade security ensures your data and API keys are protected with industry-standard encryption.

Authorization: Bearer YOUR_API_KEY

Replace YOUR_API_KEY with your actual API key from your dashboard.

API Endpoints

Our enterprise-grade API provides pharmaceutical companies and AI workflows with access to regulatory documents and data through RESTful endpoints. All endpoints return structured JSON responses optimized for integration into your applications and workflows.

Base URL

https://api.biocore.com/v1

Common Endpoints

  • GET /drugs - List all drugs
  • GET /drugs/{id} - Get drug details
  • GET /regulatory-documents - Search regulatory documents
  • GET /jurisdictions - List supported jurisdictions
  • GET /adverse-reactions - Get adverse reaction data
  • POST /search - Advanced search across all data

Rate Limits

API rate limits are applied per API key to ensure fair usage and optimal performance for all pharmaceutical companies and AI workflows. Rate limits are customized based on your organization's usage patterns, deployment requirements, and compliance needs.

Enterprise Plans: Custom rate limits tailored to your organization's production workloads and integration requirements. Contact us to discuss rate limits that meet your specific needs.

Supported Jurisdictions

Biocore provides pharmaceutical companies with regulatory data from 8 major pharmaceutical markets worldwide, ensuring comprehensive coverage for global regulatory compliance:

  • United States (FDA)
  • European Union (EPAR)
  • Canada (Health Canada)
  • United Kingdom (MHRA)
  • Australia (TGA)
  • France (ANSM)
  • Japan (PMDA)
  • Switzerland (Swissmedic)

Data Attribution

Important: Biocore aggregates regulatory data from authoritative pharmaceutical regulatory sources and research databases. We are not the original source of regulatory data. All regulatory information originates from official pharmaceutical regulatory authorities (FDA, EMA, MHRA, etc.) and publicly available research databases. Biocore provides infrastructure and API access to this aggregated data. For critical regulatory compliance decisions, verify information directly with original regulatory sources. See our data sources for complete attribution.

Data Formats

All API responses are returned in structured JSON format optimized for pharmaceutical applications. Regulatory documents are available in multiple formats to support various compliance workflows:

  • JSON: Structured data for programmatic access
  • PDF: Original regulatory documents
  • HTML: Formatted web-friendly documents
  • Excel: Exportable spreadsheet format

Search & Filtering

Our API supports advanced search capabilities across all regulatory data, designed for pharmaceutical companies managing complex compliance requirements. Use query parameters to filter results by jurisdiction, date, document type, and more to streamline your regulatory workflows.

GET /drugs?jurisdiction=US&date_from=2024-01-01&document_type=label

Search for drugs in the US jurisdiction with labels updated since January 2024.

Security & Compliance

Biocore is committed to maintaining the highest security standards for pharmaceutical companies and enterprise applications. Our production-ready infrastructure is:

  • Security controls aligned with SOC 2 Type II standards (security documentation available for enterprise customers)
  • HIPAA-ready infrastructure (BAA available upon request for PHI processing)
  • GDPR-ready infrastructure with data protection controls
  • Built with 21 CFR Part 11 considerations (audit trail capabilities included)
  • Encrypted data transmission (TLS 1.3) and data at rest (AES-256)
  • Regular security audits and penetration testing
  • Comprehensive audit logging and monitoring

Data Residency Options

Biocore offers flexible data residency options to meet your organization's requirements:

  • US Data Residency: US data center options available for customers requiring data to remain within US jurisdiction (specified in Order Form)
  • EU Data Residency: EU data center options available for GDPR-compliant data residency within the EEA
  • Self-Hosted: Complete data sovereignty with zero data collection by Biocore—ideal for strict compliance requirements

Deployment-Specific Compliance

Managed Hosting: Minimal data collection (user authentication only). Customer data access limited to system operations with customer authorization.

Self-Hosted: Zero data collection by Biocore. Customer has complete control over all data, infrastructure, and compliance. Customer assumes full responsibility for validation and compliance.

Export Control & Cross-Border Compliance

Biocore complies with applicable export control regulations (EAR, ITAR) and implements data transfer safeguards:

  • Standard Contractual Clauses (SCCs) for EU data transfers
  • Sanctions screening (OFAC, UN, EU)
  • Encrypted data transfers (TLS 1.3)

For detailed compliance information: Please refer to our Terms of Service and Privacy Policy for comprehensive information about data residency, government data access, export controls, and regulatory compliance.

Need Help?

If you have questions or need assistance integrating Biocore's regulatory infrastructure into your pharmaceutical applications or AI workflows, please contact our support team:

Email: support@biocore.com

Documentation: docs.biocore.com