// INDUSTRY SOLUTION | PHARMA

Pharma AI: Maximum Precision for an Industry Without Tolerance for Error.

In pharma, precision is vital, documentation errors are not an option. Xanevo delivers AI solutions for pharma and life sciences that turn your highly complex product data into valid, regulation-compliant information and secure global compliance workflows through smart automation.

// THE PROBLEM

Why manual review processes in pharma are the competitive disadvantage

How can AI be used safely in the pharma industry?

By building pipelines validated, documented, and auditable. AI does not replace the reviewer, it relieves them from repetitive standard checks. Every AI step has an audit trail, every decision is traceable, every data source is versioned. GxP-compliant without taking the reviewer out of the loop.

// OUR APPROACH

Three modules for content, compliance translation, and data integrity

Module 1: Regulated content factory

Automated creation of fact sheets and package inserts from structured lab data. With validation layers that check every output against source and regulatory rules.

Fact sheets from study data

Package inserts with compliance check

Versioning per market

Module 2: Global compliance translation

Medically precise AI translations with strict translation memory for consistent terminology. Glossaries per market variant.

MedDRA and WHO terminology

Translation memory per product

Market-specific adaptation

Module 3: Data integrity and governance

Securing golden records for every preparation across all markets. Audit trail per data field, lineage tracking, clear source-of-truth rules.

Audit trail per field

Lineage tracking

Sources of truth per data type

// COMPARISON

Manual pharma processes
vs. validated AI pipelines

Challenge

Classical handling

Xanevo Approach

Fact-sheet update

Manual adaptation per market

Automated generation with validation

Translation consistency

Separate translator per market, risk of deviation

Translation memory plus MedDRA glossaries

Audit preparation

Weeks of manual prep

Audit trail at the click of a button

Substance change update

Manual per market, high error rate

Pipeline run, validated

// FAQ

Frequently Asked Questions

We deliver documented, versioned pipelines with audit trail. Computer System Validation (CSV) follows established frameworks (GAMP 5). Every run is traceable.

With translation memory plus MedDRA glossaries yes, but the final output always passes through qualified human review. AI does prep, the reviewer decides.

Stays untouched. We build a master layer on top that's consolidated and auditable. We do not change ERP or LIMS.

Connected solution clusters

Regulatory Data Upkeep

Golden records for preparations. Audit trail, lineage, versioning per market.

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Automated Pharma Content

Fact sheets, package inserts from study data. With compliance validation.

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Precise Localization

MedDRA terminology, translation memory per product, market-specific glossaries.

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// PHARMA

Request a Compliance Check for Your Content Workflows.

We analyze your regulatory processes, data lineage, and translation pipelines in 60 minutes. Outcome: GxP-compliant AI roadmap with clear validation steps.

60 minutes remote

.

With your QA manager

.

GxP validation experience