Skip to main content
Production-Ready Infrastructure

Regulatory API
Infrastructure

Architect production-ready regulatory compliance APIs through unified multi-jurisdiction infrastructure. We engineer automated compliance monitoring frameworks to eliminate manual regulatory work across FDA, EPAR, and NDC jurisdictions.

Schedule a DemoLogin
Enterprise-Grade Security
8 Jurisdictions
Managed Infrastructure
Infrastructure for AI Workflows

Build with regulatory data,
not infrastructure.

Enterprise-grade regulatory compliance infrastructure for pharmaceutical companies and AI workflows. Integrate pharmaceutical regulatory compliance data into any product through our unified API. We handle updates, monitoring, and multi-jurisdiction synchronization—you focus on building.

Schedule a Demo

Regulatory sources powering Biocore

Comprehensive data integration from leading pharmaceutical and biochemical sources worldwide

BIOCORE

Regulatory & Compliance

Government regulatory agencies for drug approvals and safety

8
DailyMed (US) logo
DailyMed (US)
MHRA (UK) logo
MHRA (UK)
EMA (EU) logo
EMA (EU)
Health Canada logo
Health Canada
SwissMedic logo
SwissMedic
TGA (AU) logo
TGA (AU)
ANSM (FR) logo
ANSM (FR)
PMDA (JP) logo
PMDA (JP)

Clinical Research & Literature

Clinical trials, scientific literature, and integrated drug information

4
ClinicalTrials.gov logo
ClinicalTrials.gov
PubMed logo
PubMed
DrugCentral logo
DrugCentral
NCATS Drug Data logo
NCATS Drug Data

Chemical & Compound Databases

Chemical structures, compounds, proteins, and biochemical data

5
PubChem logo
PubChem
ChEMBL logo
ChEMBL
ClassyFire logo
ClassyFire
UniProt logo
UniProt
OpenFDA UNII logo
OpenFDA UNII

Data Attribution

Biocore aggregates and structures regulatory data from the authoritative pharmaceutical regulatory sources and research databases listed above. We are not the original source of this 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.

Our Products

Production-ready regulatory infrastructure designed for pharmaceutical technical teams. Built for scale, engineered for compliance, optimized for integration velocity.

Drug Insight

Document Comparison Platform
Comprehensive medical regulatory document comparison tool designed for pharmaceutical companies. Compare FDA, EPAR, and NDC documents across versions, jurisdictions, and segments with intelligent document analysis to identify critical regulatory changes.
Cross-version document comparison across multiple jurisdictions
Segment-level change detection for adverse reactions and clinical pharmacology
Multi-jurisdiction comparison (US, EU, CA, UK, AU, FR, JP, CH)
Export capabilities in HTML, PDF, and Excel formats
Learn More

Biocore Slim API

Lightweight API for AI Workflows
Enterprise-grade regulatory infrastructure designed for AI workflows. 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.
Select endpoints optimized for AI workflow integration
Lightweight and fast response times
Structured JSON data format
Simple API key authentication
Learn More
AI Workflow Infrastructure

Biocore MCP

MCP Protocol Infrastructure
Coming Soon
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.
Native MCP (Model Context Protocol) integration
Natural language query support for regulatory data
Direct integration with AI assistants and chatbots
Structured data format optimized for LLM consumption
Learn More

Platform Capabilities

Enterprise-grade features built into every Biocore product. Managed infrastructure, enterprise security, and multi-jurisdiction data access designed for pharmaceutical compliance requirements.

Managed Infrastructure

Biocore's managed cloud infrastructure handles infrastructure updates, monitoring, and maintenance automatically. Customers receive advance notice of regulatory compliance updates and can coordinate with our team for validation planning. Designed to facilitate your validation process with comprehensive documentation and support.
Advance notification of system updates (minimum 30 days)
Change control documentation and validation impact assessments provided
Rollback procedures available if updates impact validated processes
Documentation and guidance to support your validation requirements per GxP
Applies to managed hosting; self-hosted deployments have different responsibilities
Minimal data collection: Only user authentication information collected
Customer data access: Limited to system operations with customer authorization

Enterprise Ready

Production-ready solutions built by a team with 12+ years of experience supporting US pharmaceutical companies. Built with compliance considerations for 21 CFR Part 11, HIPAA, and GDPR. Security controls aligned with industry standards including encryption, access controls, and audit logging. Quality assurance processes include human verification and automated testing. Compliance documentation and certifications available upon request.
Security controls aligned with SOC 2 Type II standards (security documentation available for enterprise customers)
Built with 21 CFR Part 11 considerations (audit trail capabilities included)
HIPAA-ready infrastructure (BAA available upon request for PHI processing)
Designed to support GxP validation requirements (documentation support available)
Audit trail capabilities for compliance tracking
Production-ready code with comprehensive testing
Self-hosted option: Zero data collection, complete customer data sovereignty
Managed hosting: Minimal data collection (user authentication only)

Multi-Jurisdiction Data Access

Access regulatory documents across 8 major pharmaceutical markets (US, EU, CA, UK, AU, FR, JP, CH) through a single unified API. Biocore aggregates FDA, EPAR, and NDC data, providing structured access to regulatory documents. Designed to support your compliance workflows with advance notification of data updates for validation planning.
Structured access to regulatory documents across 8 jurisdictions
Advance notification of data updates for validation planning
Jurisdiction-specific compliance documentation available
Data residency options available for specific jurisdictions
Single unified API for FDA, EPAR, and NDC data access
Cross-jurisdiction version comparison capabilities

Regulatory Data Access Across
Pharmaceutical Sectors

From regulatory affairs to clinical research, Biocore's production-ready API infrastructure provides structured access to regulatory data across diverse pharmaceutical sectors. Reduce manual regulatory data collection and ensure data accuracy across all jurisdictions. Designed to support your compliance workflows and help you meet regulatory requirements per GxP.

Regulatory Affairs Management

Transform manual regulatory document tracking into automated API-driven workflows. Compare FDA, EPAR, and NDC documents across jurisdictions, track version changes, and access regulatory data efficiently. Designed to support your compliance management and regulatory reporting workflows.
Document version comparison across jurisdictions
Regulatory change tracking and notifications
Multi-jurisdiction regulatory document access

Pharmaceutical Document Comparison

Drug Insight document comparison tool uses Biocore API to compare regulatory documents across versions, jurisdictions, and segments. Identify changes in adverse reactions, clinical pharmacology, boxed warnings, and more. Designed to support your compliance workflows and help you make informed compliance decisions.
Cross-version document comparison
Segment-level change detection
Multi-jurisdiction comparison
HTML, PDF, and Excel export formats

Clinical Research & Development

Integrate regulatory data directly into clinical research platforms. Access structured FDA, EPAR, and NDC data for literature reviews, competitor analysis, and regulatory data analysis without manual data entry.
Structured regulatory data access
Intelligent search across segments
Automated data export for research databases

Human-verified engineering process

Biocore combines automated API development with pharmaceutical domain expertise to deliver production-ready regulatory APIs. Built with compliance considerations for 21 CFR Part 11, HIPAA, and GDPR. Every endpoint undergoes quality assurance processes including human verification and automated testing. Documentation support available to facilitate your GxP validation process and help you meet regulatory requirements.

Regulatory Data Analysis

Analyzes target regulatory systems (FDA, EPAR, NDC) at the data level
Examines document structures, segment codes, and regulatory data formats
Identifies optimal API architecture across multiple jurisdictions

Automated API Development

Generates API endpoints, data models, and search algorithms from regulatory specifications
Learns pharmaceutical terminology, segment mappings, and cross-jurisdiction patterns
Creates intelligent APIs designed with compliance considerations for pharmaceutical regulatory data access

Expert QA

Pharmaceutical domain experts verify every endpoint
Validates data accuracy and regulatory compliance considerations
Ensures FDA, EPAR, and NDC data accuracy with proper segment mapping
Built with compliance considerations for GDPR, HIPAA, and 21 CFR Part 11
QA documentation available to support GxP validation requirements

Automated Maintenance

Continuously monitors regulatory changes across all jurisdictions
APIs automatically update when FDA, EPAR, or NDC requirements change
Advance notification provided for validation planning
Designed to facilitate your validation process for updates per GxP requirements

Ready to Transform Your
Regulatory Workflow?

Architect production-ready regulatory compliance APIs through unified multi-jurisdiction infrastructure. Eliminate manual regulatory work, reduce operational overhead, and ensure accuracy across FDA, EPAR, and NDC jurisdictions.