Regulatory Submission Translation

Ensure your medical documents are approval-ready and meet
the local regulatory standards with ease

Our Translators are Subject Area Experts Who Understand the Complexities of Regulatory Submissions

Each translator holds a Ph.D. or Master's degree in the relevant field, and holds verifiable experience translating regulatory documents.

Regulatory Submission Documents We Specialize in

  • Instructions for Uses (IFUs)
  • Summary of Product Characteristics (SmPC)
  • Packaging
  • Labeling
  • Regulatory Correspondence
  • Package Information Leaflets (PILs)
  • Chemistry, Manufacturing and Control Documentation (CMC)
  • Patient Prescribing Information
  • Common Technical Documents (CTDs)
  • Quality Review Documents (QRD)
  • Pharmaceutical Product Information
  • Regulatory Dossiers
  • Standard Operating Procedures (SOPs)
  • Validation Documents

Our Technology and AI Solutions

Leverage our extensive 8+ years of demonstrated AI proficiency. Our committed team of over 70 experts specializes in delivering tailored data, technology, and AI solutions. We harness proprietary enterprise data to address your distinctive challenges, offering insights that contribute to the development of compelling narratives.

Proprietary Machine Translation Engine

Our translation engines are built and managed by us, ensuring that we have control over the security of your data and the precision of the translations. With our APIs, you can construct personalized machine translation solutions tailored to meet your specific requirements.

Customer Portal

Take complete command of your translation requirements with our customer portal. Receive immediate project quotes, securely exchange files, and track progress using an interactive dashboard. Download finalized files, manage payments, and access invoices conveniently at your discretion.


Effortlessly integrate foreign language terminology into technical documents, particularly in Pharmaceuticals, Technology, and diverse scientific and social studies, using our multilingual terminology tool. With over 150,000 terms available in 10+ languages, ensure precision and consistency across your content.

Translation Management System

Enago Life Science's Translation Management System (TMS) streamlines and enhances the entire translation project. Benefit from features such as translation memories to minimize repetitive tasks, real-time application of approved terminology, suggestions for consistent past translations, and optimized review workflows through our quality assurance feature.

CAT Tools

Enago Life Science's CAT tool enables translators to produce precise, high-quality translations efficiently. It streamlines processes by storing translation memories and term bases for future accuracy, integrates seamlessly with client platforms for content ingestion, minimizes repetitive tasks, and offers various features to ensure top-notch translation quality.


Experience our exclusive online grammar checker designed specifically for technical documents. Conducting over 3000 grammar checks, it enhances tone and style, provides advanced writing tips, and is applicable to all subjects, ensuring the delivery of error-free documents.

Enago Reports

Create comprehensive reports that enhance the quality, integrity, and impact of multiple categories of documents in a fast, accurate, and detailed manner with the help of advanced AI

Learn how we help you eliminate language barriers for your regulatory submissions


Life Science Localization
You Can Trust

We've designed our localization experience with certified processes and efficient technology, ensuring a seamless delivery of consistent quality that enhances client satisfaction.

Specialized Subject-
Area Matching

Driven Technology

24x7 Dedicated
Localization Manager

Localization Solutions

In-House Expertise

ISO-Certified Processes

Our Key Contributions to the Life Science Industry

What do our clients say?

Our Memberships

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