PHARMA AND LIFE SCIENCES

Compliant Data Sharing Across Every Market, Format, and Regulatory System

Whether you're filing with the FDA, sharing data with CROs, or preparing for inspection, Limina removes sensitive identifiers without destroying the clinical and commercial context your teams need.

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HOW IT WORKS

From Raw Clinical Data to Regulatory-Ready

Three steps to compliant, usable research data—whether you're filing with the FDA, sharing across trial sites, or protecting CCI in procurement contracts.

Detect PHI and CCI Across Every Document

Find patient identifiers, confidential company information, supplier details, pricing terms, and trade secrets across clinical trial documents, procurement contracts, EHR exports, and regulatory filings in any format, any language.

De-identify Without Losing Research Value

Remove identifiers while preserving statistical properties, temporal relationships, and clinical context. Redact, pseudonymize, or replace with synthetic PII depending on whether the output is going to the FDA, a research partner, or an AI model.

Prove Your Compliance Holds Up

Expert determination-ready outputs that meet HIPAA Expert Determination standards. Audit trails built in. Independent validation available through our partner network for FDA submissions, IRB review, and EMA filings.

Built for Global Pharma Operations

Clinical trial data spanning formats and languages. FDA filings with multilingual annexes. Procurement contracts with intellectual property. Limina handles it all through a single deployment.

Process PHI and CCI Across 50+ Languages

Detect region-specific identifiers—European health card numbers, Japanese My Number IDs, Canadian SINs—alongside standard PHI without rebuilding pipelines for each market.

Accelerate Regulatory Submissions

FDA filings, EMA submissions, and global regulatory packages de-identified in minutes instead of days—removing compliance bottlenecks that would otherwise slow commercial timelines.

Protect CCI in Procurement and R&D Documents

Remove pricing terms, supplier identities, proprietary specifications, and trade secrets from procurement contracts before FDA inspection requests. Define what constitutes CCI once—Limina applies those rules consistently across thousands of contracts in any language, eliminating the compliance risk that comes from regional teams applying different standards.

A Privacy Layer for Every Data Pipeline

Create a privacy layer for data flowing through translation services, data intelligence platforms, and commercial operations. De-identification happens before data enters third-party services, eliminating exposure risk while maintaining operational workflows. Your clinical, commercial, and procurement data never leave your infrastructure.

Enable Real-World Evidence Studies

De-identification preserves the statistical properties RWE research needs. Major CROs use Limina to prepare large-scale real-world patient data for ML analytics and comparative effectiveness research, with expert determination reports that prove de-identification meets HIPAA standards for research use.

CUSTOMER WIN

Boehringer Ingelheim

48 hours → Minutes

Medical inquiry response time across four languages

Enterprise-wide

Deployed across the entire Data Foundation layer

US, Europe, China, Japan

Global compliance achieved from one deployment

The Platform Was Ready. The Data Wasn't.

Boehringer Ingelheim built an internal medical Q&A platform to help teams instantly find answers to inquiries from doctors, patients, pharmacists, and wholesalers worldwide. But the platform couldn't launch. Medical inquiries contained sensitive information, doctor details, and addresses in plain text and PDFs across multiple languages, making cross-regional data sharing non-compliant.

Limina made it launchable.

Limina was deployed to anonymize medical inquiries and complex PDF documents before they entered the platform, processing French, English, Spanish, and German without rebuilding pipelines for each language. What started as a single use case was elevated to Boehringer Ingelheim's enterprise Data Foundation layer, making anonymized data available to all downstream applications. The US market, previously excluded over compliance concerns, became one of the platform's largest data sources.

We couldn't have launched without proper anonymization. It was critical for compliance, especially to include US data, which represents one of our larger customer bases.

Israel Gonzales Salas

Data Engineer, Boehringer Ingelheim

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Ready to Remove the Compliance Bottleneck?

Talk to our team about your use case. Most customers are up and running in days, not months.

Frequently Asked Questions

How does Limina handle multilingual regulatory submissions?

We process regulatory documents in 52 languages through the same deployment. FDA submissions in English, EMA filings with German and French translations, and Japanese regulatory packages all flow through identical workflows—without rebuilding pipelines for each market.

What's the difference between Safe Harbor and Expert Determination?

Safe Harbor follows HIPAA's prescriptive list of identifiers to remove. It's straightforward but often destroys too much clinical context for research use. Expert Determination uses statistical methods to prove re-identification risk is very small, preserving more data utility for real-world evidence studies and regulatory submissions where you need demographic details, dates, and geographic information. Limina provides expert determination-ready outputs and formal reports through our partner network with independent statistical validation.

How does Limina handle CCI redaction for FDA inspection readiness?

Your legal and compliance teams define what constitutes CCI, trade secrets, and confidential information. Limina executes those definitions consistently across thousands of contracts—pricing terms, supplier identities, proprietary specifications, and financial projections get detected and redacted uniformly, with audit trails documenting what was identified, what rules were applied, and what review steps were completed.

Can we use de-identified data for real-world evidence studies and AI training?

Yes. De-identification preserves the statistical properties RWE research and AI training require. Major CROs use Limina to prepare large-scale real-world patient data for ML analytics. Research institutes like CHEO use it to share anonymized production EMR data for LLM development across institutions. Expert determination documentation proves your data are defensible for commercial use, research, and regulatory review.

Does our data leave our environment?

No. Limina deploys as a container in your on-premises environment or VPC. All processing happens inside your existing security perimeter—no third-party cloud processing, no external transmission. This matters especially for pharma: clinical data, procurement contracts, and competitive information never flow to external services before they're protected.

Can we share de-identified data with research partners and CROs?

Yes. Expert determination-ready outputs mean your de-identified data are defensible for sharing with research partners, CROs, and academic collaborators. Independent validation from third-party partners provides the audit documentation research agreements and data sharing agreements require.