Translation API for Pharma Regulatory Submissions

    Prevent filing delays from formatting errors. Bluente’s API translates complex regulatory submissions while perfectly preserving layouts in DOCX and scanned PDFs.

    Test out our translation API

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    API connectivity and integration visualization

    Why Pharma Teams Choose Bluente's Regulatory API

    Regulatory submissions leave no room for formatting errors. A broken table or misaligned numbering in a dossier can stall an approval and trigger costly re-submissions. Generic translation APIs were built for plain text strings, not the complex, multi-page file formats that regulatory affairs teams work with every day.

    Bluente's API is purpose-built for file-based translation. It handles scanned PDFs with advanced OCR, preserves legal numbering and section hierarchies, and outputs bilingual, review-ready documents so your team can verify translations before filing.

    With support for 22 document formats, 100+ languages, batch upload, webhook notifications, and live status tracking, Bluente integrates directly into your existing regulatory workflows. Enterprise-grade encryption, automatic file deletion, and certifications including SOC 2, ISO 27001:2022, and GDPR compliance meet the stringent security standards required in pharma environments.

    What's included in our Translation API?

    Our Translation API gives you fast, secure, and scalable access to high-quality translations across 120+ languages.

    Our advanced terminology recognition delivers a 99.7% accuracy rate, trusted by lawyers and professionals who require precision.

    Translation API

    Fast, reliable translation API for seamless integration into your applications.

    • 120+ Languages

      Comprehensive language coverage for global reach

    • RESTful JSON API

      Simple integration with clear documentation

    • End-to-end encryption

      Secure data transmission and processing

    • Batch upload with live status tracking

      Process multiple files with real-time updates

    • Webhook notifications for job completion

      Get notified when translations are ready

    • Multi-format support: DOCX, PDF, XML, JSON, images

      Handle various file types seamlessly

    • 99.9% uptime backed by global CDN

      Reliable service with worldwide infrastructure

    • Advanced layout formats & API configuration

      Bilingual output, tracked changes, and layout preservation through API parameters

    How it works

    Our streamlined process delivers fast, accurate translations through our enterprise-ready API.

    1

    Review API Documentation

    Explore our comprehensive API documentation, code examples, and integration guides to understand our translation capabilities and requirements.

    2

    Request for Trial Account

    Contact our team to request a trial account. Provide your use case and integration requirements for review and approval.

    3

    Integrate and test

    Build your integration using our RESTful API. Test and validate translations with your content.

    4

    Deploy and scale

    Go live with confidence using our production-ready infrastructure. Monitor usage, track performance, and scale seamlessly as your needs grow.

    Frequently Asked Questions

    Get answers to common questions about our Translation API. Learn about supported languages, performance, integration options, and how to get started with our enterprise-ready solution.

    Bluente's API supports 22 file formats including DOCX, PDF, XML, DITA, XLSX, PPT, PPTX, HTML, and scanned image files such as PNG, JPG, and JPEG. This covers the full range of document types commonly used in regulatory dossiers, clinical trial filings, and submission packages across major regulatory bodies.

    Bluente's layout-aware translation engine preserves tables, charts, footnotes, legal numbering, headers, footers, and section structures exactly as they appear in the original document. For scanned PDFs or image-based files, advanced OCR first converts non-selectable text into editable content before translation, maintaining the original layout throughout the process.

    Yes. Bluente is SOC 2 compliant, ISO 27001:2022 certified, and GDPR compliant. All files are processed with end-to-end encryption and are automatically deleted after processing. These certifications meet the stringent confidentiality and data security requirements expected in pharmaceutical and regulatory environments.

    Bluente generates side-by-side bilingual documents that place the original text alongside the translation for direct comparative review. This makes it straightforward for regulatory affairs managers and compliance officers to verify accuracy before submission, reducing the risk of filing errors.

    Yes. The API supports batch upload of multiple documents simultaneously, with live status tracking and webhook notifications for job completions. This allows development teams and regulatory operations to automate high-volume translation workflows without manual intervention between each file.

    Bluente's API supports translations across 100+ languages, enabling pharmaceutical companies to prepare regulatory submissions for multiple markets and regional authorities without switching between different translation providers or tools.

    Bluente provides a RESTful JSON API with comprehensive documentation, code examples, and API keys issued after an access review. The API is designed to integrate with existing enterprise systems and regulatory workflow platforms. Your team can test and validate translations in a staging environment before deploying to production infrastructure.

    Bluente's API is backed by a 99.9% uptime guarantee supported by a global CDN. This reliability is critical for time-sensitive regulatory submissions where workflow interruptions can cause filing delays or missed deadlines with regulatory authorities.

    Contact Sales to Access the API

    Speak to our team about your regulatory submission workflows and integration requirements. Bluente's API is reviewed for qualified applications to ensure the right fit for your compliance environment.