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Regulatory Intelligence Infrastructure

Regulatory Intelligence Infrastructure for Pharma

Enterprise-grade regulatory intelligence infrastructure for pharmaceutical companies and AI workflows. Structured access to FDA, EMA, and PMDA data — powering compliance, analytics, and AI-driven regulatory workflows.

GET api.biocore.com/v1/labels/search?drug=atorvastatin
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200K+ Drug Labels
8 Jurisdictions
99.9% Uptime SLA
<24h Label Updates
Global Regulatory Network

8 Jurisdictions · Live Sync

Active
USFDA
EUEMA
UKMHRA
JPPMDA
CAHlth CA
AUTGA
FRANSM
CHSwissMed
Recent UpdatesLive feed
FDA

Atorvastatin 80mg

Label Updated

2h
EMA

Ozempic 2mg

New Approval

14h
MHRA

Dupixent 300mg

Label Change

1d
GxP Validated · SOC 2 Type II · Audit Ready
Built for teams building:
AI Drug DiscoveryRegulatory Affairs AutomationPharma Analytics PlatformsClinical Research ToolsMarket Authorization WorkflowsMCP-Enabled AI Agents
200K+
Normalized Drug Labels
8
Regulatory Jurisdictions
<5min
Integration to First API Call
99.9%
Platform Uptime
17+
Data Sources
GDPR
& HIPAA Compliant
Infrastructure

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.

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Data Coverage

Regulatory sources powering Biocore

17 authoritative sources across 3 domains — continuously synchronized, structured, and served through a single API.

Biocore aggregates and structures data from official pharmaceutical regulatory authorities (FDA, EMA, MHRA, etc.) and publicly available research databases. Biocore provides infrastructure and API access — not the original source.

Products

Built for Pharma Teams

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

OneLabel

Drug Label Intelligence 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
Use Cases

Who builds on BioCore.

From pharma AI startups to enterprise analytics platforms, BioCore powers the regulatory data layer for teams that can't afford to get it wrong.

Pharma AI Builders

Ground your LLMs in verified regulatory data

Build AI assistants, copilots, and search tools grounded in normalized, audit-ready drug label data. BioCore's MCP server gives your models a structured, always-current regulatory knowledge base — without building your own ingestion pipeline.

6 months of data engineering → daysIntegration time reduction
Analytics Platforms

Power competitive intelligence with live data

Track competitor label changes, new approvals, and safety updates across all major markets — with structured data that's always current and diff-ready. Monitor 8 jurisdictions through one integration instead of 8 separate data sources.

8 jurisdictionsCovered in a single API
Regulatory Automation Platforms

Automate RA workflows on a single structured data layer

Build platforms that automate regulatory affairs workflows — submission tracking, label change monitoring, and multi-market compliance checks — on top of a single normalized data layer covering FDA, EMA, PMDA, and Health Canada. No manual portal scraping required.

4 hours → 20 minutesPer-market label monitoring time
Clinical Decision Support

Embed always-current prescribing information

Integrate structured, normalized drug label data into clinical decision support systems, formulary tools, and prescribing platforms via the Biocore Slim API — with sub-50ms response times under production load. Always current, no manual refresh cycles.

<24hLabel update latency
Pharmacovigilance

Detect safety signal changes before they escalate

Subscribe to webhook events for boxed warning changes, new contraindications, and adverse event section updates across your entire drug portfolio. Use OneLabel to compare label versions in minutes — replacing manual monitoring workflows.

100%GxP audit trail coverage
Global Market Access

Track regulatory approvals across 8 jurisdictions

Monitor new product approvals, label harmonization, and regulatory divergence across the US, EU, Japan, Canada, Australia, and more — from a single API integration. 200K+ normalized labels indexed, no separate data feeds per market.

200K+Normalized labels indexed
Start integrating →Enterprise compliance docs →
Discuss your use case
Platform

Everything You Need to Build Regulatory Intelligence

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

Core API

Normalized Drug Label Data

Every drug label from FDA DailyMed, EMA, PMDA, and 6+ other agencies — parsed, normalized, and delivered in a consistent JSON schema. No more wrestling with SPL, PDF, or HTML source formats.
FDA DailyMed, EMA, PMDA, and 6+ agencies in one schema
Consistent JSON output regardless of source format
No SPL, PDF, or HTML parsing on your end
Webhooks

Regulatory Update Tracking

Real-time webhooks fire within hours of any label update, new approval, or safety communication. Never miss a boxed warning change or new contraindication again.
Webhooks delivered within hours of any label change
Covers new approvals, boxed warnings, and safety comms
Structured payloads — no scraping or polling required
Reference Data

Manufacturer Mapping

Structured data on MAHs, applicants, and manufacturers — linked to their products across jurisdictions. Build competitive intelligence tools without the data assembly work.
MAHs and applicants linked to products across jurisdictions
Cross-jurisdiction manufacturer identity resolution
Ready for competitive intelligence and market analysis
Versioning

Label Version History

Full version history for every label — diff-ready, timestamped, and linked to the originating regulatory submission. Track exactly what changed, when, and why.
Complete history for every label, diff-ready
Timestamped and linked to originating submission
Track what changed, when, and why — audit-trail friendly
Developer-First

Structured APIs

REST and GraphQL endpoints with full OpenAPI documentation, SDKs for Python and Node.js, sandbox environment, and enterprise SLAs. Integrate in days, not months.
REST + GraphQL with full OpenAPI documentation
SDKs for Python and Node.js, plus a sandbox environment
Enterprise SLAs — integrate in days, not months
Enterprise

Enterprise Platform

SOC 2 Type II, 21 CFR Part 11, and GDPR-ready infrastructure — AES-256 encryption at rest and in transit, managed updates, change control documentation, and data residency options across 8 jurisdictions.
SOC 2 Type II controls, 21 CFR Part 11, and GDPR compliance
AES-256 encryption at rest and TLS 1.2+ in transit
Data residency options across US, EU, CA, UK, AU, FR, JP, CH
Book a Live Walkthrough

No commitment — we'll walk you through the API live.

Deployment
Cloud or On-Premise
Uptime SLA
99.9% Guaranteed
Compliance
GxP · SOC 2
Support
24/7 Enterprise SLA
The Problem

Build vs Buy

Building your own regulatory data pipeline costs 6–18 months and a dedicated team. Biocore replaces that with a single API call.

✕

Without Biocore

  • ✕6–18 months to build regulatory data pipelines
  • ✕Dedicated team to monitor 8+ regulatory sources
  • ✕Fragmented data across PDF documents and portals
  • ✕Manual comparison work across jurisdictions
  • ✕No structured access for AI/LLM workflows
  • ✕Compliance gaps from missed regulatory updates
✓

With Biocore

  • Production-ready API in minutes, not months
  • Managed infrastructure — we handle all updates
  • Structured, validated data across 8 jurisdictions
  • Automated document comparison via OneLabel
  • MCP protocol support for AI agent workflows
  • Advance notice of regulatory changes for validation

Ready to skip the build? Get structured regulatory data via API in under 5 minutes.

Schedule a Demo
Architecture

BioCore sits between raw regulatory data and the products you build.

We handle all the ingestion, normalization, and validation. You get clean, structured data via API — and focus on building.

Raw Regulatory Sources
FDADailyMed
EMAEPAR
PMDAPharmaceuticals
Health CanadaDrug Products
TGAARTG
MHRAYellow Card
ANSMRCP
SwissmedicArzneimittel
+9 more
Ingest · Parse · Normalize · Validate
BioCore
Regulatory Data Infrastructure
Continuous ingestion & parsingSchema normalizationVersion diffing & historyManufacturer mappingGxP audit trailREST & GraphQL APIsReal-time webhooksSDKs & OpenAPI spec
REST API · GraphQL · Webhooks · SDKs
Applications Built on BioCore
Powered by BioCore
OneLabelDrug label intelligence
Pharma AI ToolsLLM-powered assistants
Competitive IntelMarket monitoring
Clinical DecisionPrescribing & safety
PV SystemsPharmacovigilance
Your product →
Get Started

Ready to Transform Your Regulatory Workflow?

From single-developer API access to enterprise infrastructure — Biocore has a path for your team.

Developer

Start with the API

Full access to Slim API with OpenAPI docs. Structured regulatory data in minutes.

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Enterprise

Full Infrastructure

Dedicated infrastructure, SLA, onboarding, and validation support for GxP compliance.

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Live Demo

See It In Action

30-minute walkthrough of the full platform with a member of our team.

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