Pharmaceutical translation for accurate global compliance

Managing medical documentation across international markets requires precise language handling and strict regulatory adherence. Modern pharmaceutical companies face mounting pressure to deliver compliant translations that meet diverse regulatory standards while accelerating time-to-market for life-saving treatments. 

XTM provides pharmaceutical translation solutions that address these critical challenges through purpose-built workflows, automated quality controls, and comprehensive audit systems. Our platform helps pharmaceutical organisations maintain accuracy, ensure compliance, and reduce approval timelines across all global markets.

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Trusted by teams at over 1,000 of the world’s leading organizations
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Proven results in pharma compliance worldwide

Pharmaceutical translation demands specialised approaches that standard translation tools cannot provide. XTM's platform addresses the unique requirements of medical documentation with built-in compliance features, terminology controls, and quality assurance workflows designed specifically for regulated industries.

880+

supported languages

18B

words processed annually

1300+

worldwide customers

Pharmaceutical translation complexities require specialised expertise

Medical device approvals, clinical trial protocols, and patient safety information demand flawless accuracy across multiple languages. Standard translation methods introduce compliance risks and delay market access for essential treatments.

XTM addresses these challenges with dedicated pharmaceutical translation workflows. Our platform maintains consistency, provides complete audit documentation, and reduces approval timelines whilst meeting stringent regulatory standards across all therapeutic areas.

Expedite regulatory approval with compliant pharmaceutical translation

Specialised features ensure your pharmaceutical translation projects meet regulatory requirements while reducing project duration and operational complexity.

Ensure automatic regulatory compliance

Integrated audit systems and change documentation satisfy FDA, EMA, and international regulatory standards without manual monitoring. Every translation decision receives proper documentation with complete version tracking and approval processes that meet compliance audit requirements.

A five-step diagram of an automated translation workflow: content import, translation assignment, automated QA check, reviewer approval, and publishing or exporting.

Manage terminology across all languages

Unified terminology control ensures medical terms remain consistent across every document and language combination. Avoid expensive errors with automated term verification that identifies inconsistencies before regulatory submission.

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Process high-volume documentation efficiently

Manage thousands of pages across drug labels, patient information leaflets, clinical protocols, and regulatory submissions simultaneously. Automated distribution systems connect qualified translators whilst maintaining quality standards throughout entire project lifecycles.

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Implement quality assurance protocols

Multiple review stages identify errors before final delivery through integrated linguistic and compliance verification. Medical writers, translators, and regulatory reviewers work together seamlessly within structured approval systems.

A graphic showing an approval workflow with steps for a translator, reviewer, legal/manager, and a final publishing stage, highlighting customizable steps.
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What pharmaceutical customers tell us

Dominic-Pemberton
With XTM Cloud, we can now offer all customers across the world the same level of support and access to every new product we launch more quickly while reducing costs and errors, and ensuring consistency across all content.”
Dominic Pemberton

VP of Content, RS Group

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Deepak Nagabhushana
What truly makes a difference is the people and their commitment to supporting their customers. The XTM team was able to go out of their way to create a tailored solution for us, and we’re looking at introducing even more automation in the future. The fact that they are localization experts makes a big difference as they truly understand our needs.”
Deepak Nagabhushana

Staff Localization Project Manager, GoTo

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Alex Katsambas
There’s no way we could be running the same operations today if we didn’t have the right tech stack in place.”
Alex Katsambas

Senior Head of Localization Services, FARFETCH

Farfetch
Elisabeth Feulner
Since implementing XTM Cloud, the volume of translated words for our most frequent language pairs has increased by approximately 10%. This wouldn’t have been possible without all the added automation a TMS provides.”
Elisabeth Feulner

Project Manager, Allround Service

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Vincent Rigal
XTM Cloud forms a big global ecosystem of seamlessly connected accounts to which thousands of users connect daily. Overall, the result is better quality with fewer resources.”
Vincent Rigal

CAT Tools Products Owner, Acolad

Acolad
Ronald-Egle-Ariel
We had a phenomenal setup with our content management system feeding automatically into and out of XTM. Adding SYSTRAN MT to the process made it even better. Then with the release of XTM 12.7 and neural fuzzy adaptation, we found gold. Now we’re able to harness the very best of both machine translation and human editing for outstanding cost efficiency.”
Ronald Egle

Content Systems Administrator, Ariel Corporation

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Complete pharmaceutical translation capabilities for every requirement

Essential tools created specifically for pharmaceutical organisations managing complex, regulated translation projects across international markets.

Terminology control

Centralised medical vocabulary management ensures consistent pharmaceutical translation of critical terms across all languages, documents, and therapeutic areas whilst maintaining regulatory compliance standards.

Audit documentation and reporting

Complete records of every modification, approval, and revision create compliance-ready documentation that satisfies FDA, EMA, and international regulatory authority requirements.

AI-driven quality assurance

Automated terminology validation, formatting checks, and compliance reviews identify errors before documents reach regulatory submission or patient distribution networks.

Team collaboration tools

Organised workflows connect medical writers, translators, reviewers, and regulatory teams through role-based permissions and structured approval sequences.

Integration capabilities

Direct connections with content management systems, regulatory platforms, and clinical trial management tools eliminate manual file handling and reduce project timelines.

Scalable platform architecture

Enterprise-grade security and unlimited project capacity support global pharmaceutical operations whilst maintaining data protection standards required for sensitive medical content.

60+ integrations for simplified workflows

Connect seamlessly with existing regulatory systems, content management platforms, and clinical trial infrastructure for organised pharmaceutical translation processes.

Shopify
Wordpress
HubSpot
Figma
Gemini
Open AI
Salesforce Commerce Cloud
Sitecore
GitHub
Slack
Jira
Adobe Marketo Engage
DeepL

Enterprise-grade security protocols

SOC 2 Type II certification, ISO 27001 compliance, and GDPR adherence protect sensitive pharmaceutical data throughout translation workflows.

  • Advanced encryption, role-based access permissions, and secure data centres ensure regulatory compliance
  • Regular security assessments and penetration testing validate protection standards
  • Dedicated customer success teams provide implementation guidance and ongoing optimisation
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See XTM in action

Advance your global regulatory strategy with the translation platform created specifically for pharmaceutical companies requiring audit documentation, terminology control, and compliance workflows.

Frequently asked questions

How does XTM guarantee pharmaceutical translation compliance?

XTM maintains detailed audit records for every pharmaceutical translation project, documenting modifications, approvals, and reviewer activities. Our platform satisfies FDA, EMA, and international regulatory requirements through integrated compliance workflows that track every project stage.

Version management records every document revision with timestamps and user identification. Approval sequences ensure proper review protocols before final delivery to regulatory authorities.

What distinguishes pharmaceutical translation from standard translation services?

Pharmaceutical translation requires specialised medical terminology, regulatory compliance documentation, and rigorous quality control procedures. Standard translation platforms lack the audit capabilities, terminology management, and compliance features necessary for regulatory submissions.

XTM addresses these requirements with purpose-built pharmaceutical translation workflows that ensure consistency across therapeutic areas whilst maintaining the documentation required for regulatory approval processes.

Can XTM manage large-scale pharmaceutical translation programmes?

XTM processes billions of words annually for enterprise clients managing complex pharmaceutical translation portfolios across multiple therapeutic areas and regulatory regions. Our platform scales automatically to handle simultaneous projects whilst maintaining consistent quality standards.

Automated workflows distribute content effectively whilst preserving quality requirements. Project managers can monitor progress across hundreds of documents simultaneously through centralised control panels.

How does terminology management function for pharmaceutical translation?

XTM's terminology management centralises medical vocabularies across all languages and therapeutic areas. Translators and reviewers access approved term databases that ensure consistency throughout every document and project within pharmaceutical translation workflows.

Automated term verification identifies inconsistencies during translation processes. Medical affairs teams can update terminology databases that immediately apply across all active pharmaceutical translation projects.

What integration options does XTM provide for pharmaceutical organisations?

XTM connects directly with regulatory submission platforms, clinical trial management systems, and content management tools used throughout the pharmaceutical industry. These integrations eliminate manual file transfers whilst maintaining compliance audit records for pharmaceutical translation projects.

Popular integrations include regulatory platforms, clinical data management systems, and enterprise content repositories. Custom API connections support specialised pharmaceutical technology requirements.

How rapidly can pharmaceutical companies deploy XTM?

Most pharmaceutical organisations complete XTM implementation within thirty days, including system integrations, terminology database configuration, and user training. Our customer success team provides dedicated support throughout the entire onboarding process for pharmaceutical translation requirements.

Implementation schedules depend on integration complexity and terminology database scope. Standard deployments include workflow configuration, user training, and compliance validation testing for pharmaceutical translation workflows.

What security standards does XTM maintain for pharmaceutical information?

XTM maintains SOC 2 Type II certification, ISO 27001 compliance, and GDPR adherence to protect sensitive pharmaceutical information throughout translation workflows. Our security infrastructure meets the highest standards required for regulated industries handling pharmaceutical translation data.

Information encryption, role-based access controls, and secure data centres protect intellectual property and patient information. Regular security audits validate our protection standards against evolving cybersecurity threats.

How does XTM pricing operate for pharmaceutical translation projects?

XTM offers flexible pricing models designed for pharmaceutical companies managing varying translation volumes throughout regulatory cycles. Enterprise plans include unlimited projects, users, and integration support with dedicated customer success management for pharmaceutical translation requirements.

Pricing scales based on annual translation volume and feature requirements. Custom enterprise agreements support large pharmaceutical organisations with specific compliance or integration needs for their pharmaceutical translation programmes.

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