We Built the Foundation So You Don't Have To.
Pharmaceutical regulatory data is scattered across agencies, clinical registries, and chemical databases — each with its own format, update cadence, and quirks. We built the infrastructure layer that makes it accessible, structured, and production-ready so your team can focus on the product, not the pipeline.
Data Integrity First
Every data point carries a full chain of custody. We verify before we ship — no exceptions.
Infrastructure, Not Products
We're the reliable foundation your products are built on, not a competitor. Our success is measured by yours.
Regulatory-Grade by Default
GxP compliance, audit trails, and validation documentation aren't add-ons — they're built in from day one.
Products Built on Biocore
The Problem
Pharma data infrastructure shouldn't take 18 months to build.
Every pharmaceutical engineering team faces the same wall: regulatory data is public, but getting it into a usable, structured, production-ready form is a multi-year project. Agencies publish PDFs, HTML pages, and proprietary formats — each requiring custom parsers, normalization logic, and constant maintenance as formats change.
The result is that teams spend their best engineers on data plumbing instead of the products they're actually trying to build.
What We Built
One unified API for FDA, EMA, and PMDA regulatory data.
Biocore ingests, normalizes, and validates regulatory data from 17+ primary sources across 8 jurisdictions — FDA, EMA, PMDA, Health Canada, TGA, MHRA, ANSM, and Swissmedic. We handle the pipeline so you don't have to.
Our platform is the foundation that OneLabel and dozens of pharma engineering teams are built on. Every endpoint is human-verified for regulatory accuracy and ships with GxP-ready documentation.
Our Team
12 pharmaceutical regulatory engineers, verified by domain experts.
Biocore's team combines 15+ Years of average experience across pharmaceutical regulatory affairs, software architecture, GxP validation, and enterprise engineering. Every data endpoint is reviewed and verified by a regulatory domain expert before release — not just automated.
We're a remote-first team working across FDA, EMA, and PMDA jurisdictions, with specialists in eCTD, IDMP, 21 CFR Part 11, Annex 11, and FHIR. Our quality assurance process follows CSV and GxP validation protocols so the data you build on meets the same compliance bar your product needs to meet.
Meet our pharmaceutical regulatory engineering team- Team Members
- 12
- Team Members
- Avg Experience
- 15+ Years
- Avg Experience
- Certifications
- 8+
- Certifications
- Core Skills
- 32+
- Core Skills
Want to build on Biocore's data infrastructure?
Schedule a demo or reach out directly — we're happy to walk through how Biocore fits into your stack and what integration looks like end-to-end.
About Biocore FAQ
Biocore is a pharmaceutical regulatory intelligence infrastructure platform. It provides structured API access to regulatory data from FDA (DailyMed), EMA, PMDA, MHRA, Health Canada, TGA, ANSM, and Swissmedic — 200K+ normalized drug labels across 8 jurisdictions delivered via REST API and webhooks. A Model Context Protocol (MCP) server is in development.
Most developers make their first API call within 5 minutes using Biocore's Quick Start guide. Python and Node.js SDKs are available. Enterprise integration, including GxP validation, typically takes 4–8 weeks.
Building regulatory data pipelines in-house typically takes 6–18 months and requires dedicated engineering resources to monitor 8+ agencies and handle format changes. Biocore provides production-ready API access in minutes, managed infrastructure with automatic updates, human-verified data accuracy, and GxP-ready documentation — eliminating the build and maintenance overhead.
Biocore's infrastructure is designed to support 21 CFR Part 11 and GxP compliance requirements. It includes audit trails, access controls, electronic signature support, and data provenance tracking. SOC 2 Type II, GxP validation documentation packages (IQ/OQ/PQ), and vendor qualification questionnaires are available for enterprise customers. See biocore.com/compliance for details.
Biocore was built by a team with deep experience in pharmaceutical regulatory data, spanning FDA, EMA, and PMDA sources. The company focuses exclusively on regulatory data infrastructure — ingesting, normalizing, and validating drug labels and prescribing information so engineering teams do not have to build that pipeline themselves.
Biocore operates as a remote-first company serving pharmaceutical and health-technology teams globally. Its regulatory data coverage spans eight jurisdictions — the United States, European Union, Japan, Canada, Australia, United Kingdom, France, and Switzerland — with EU data residency available for customers under European data protection obligations.