UlatusMedical Translation ServicesRegulatory Submission Translation Services
Regulatory Submission Translation

Regulatory Submission Translation

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

Johnson & Johnson
Pfizer
Sanofi
Medable
Encompass
Siemens Healthineers
Novotech

Improve the chances of acceptance of your regulatory submissions through translations done by experts in your subject area

Our team consists of subject-specific specialists committed to ensuring precision in regulatory translations. Each translator holds a Ph.D. or Master's degree in the relevant field, accompanied by extensive experience in translation and industry work with regulatory agencies such as FDA, EMA, CFDA, and PMDA. Be confident that our rigorous criteria contribute to elevating the quality of your translation outcomes.

Regulatory Submission Documents We Specialize In

  • Instructions for Uses (IFUs)
  • Summary of Product Characteristics (SmPC)
  • Packaging
  • Labeling
  • Regulatory Correspondence
  • Package Information Leaflets (PILs)
  • Pharmaceutical Product Information
  • Patient Prescribing Information
  • Common Technical Documents (CTDs)
  • Quality Review Documents (QRD)
  • Regulatory Dossiers
  • Standard Operating Procedures (SOPs)
  • Validation Documents
  • Chemistry, Manufacturing and Control Documentation (CMC)
200+

Languages

2B+

Words Translated

3000+

Expert Linguists

20+

Years of Excellence

99.4%

Client Satisfaction

200K+

Clients Worldwide

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

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.

Ulatus Customer Portal

Ulatus 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.

GlossaryX360

GlossaryX360

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

Translation Management System

Our 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

CAT Tools

Our 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.

Trinka AI

Trinka AI

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.

Reports

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.

Background

LifeScience Solutions 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

Quality-Driven Technology

24x7 Dedicated Localization Manager

ROI-Driven Localization Solutions

In-House Expertise

ISO-Certified Processes

Client Testimonials

We've helped many medical clients with the best quality medical translation services. Here's what they have to say about the quality and value we provide.

"I am grateful to the entire team for being so generous and sincere towards our requirements. At this point, we can almost blindly trust you with everything. The team barely needed our supervision and the result delivered was exactly what we were looking for. Honestly, what else could we ask for! Thank you, Ulatus. You're simply the best!"

Alvogen

"I have been using Ulatus services regularly for some time now and their quality of work is really good. The style and accuracy with which they translated my various documents was exactly what I expected it to be. I am really impressed with their team who worked closely with me to translate our vision into reality."

Abbott

"Through their excellent project management system, Ulatus surpassed all my expectations and passed fairly. Given the demands of this project, it was difficult to meet my requirements but Ulatus successfully delivered my work following the timelines and high-quality standards. It is a miracle company."

Sanofi

"I am grateful to the entire team for being so generous and sincere towards our requirements. At this point, we can almost blindly trust you with everything. The team barely needed our supervision and the result delivered was exactly what we were looking for. Honestly, what else could we ask for! Thank you, Ulatus. You're simply the best!"

Alvogen

"I have been using Ulatus services regularly for some time now and their quality of work is really good. The style and accuracy with which they translated my various documents was exactly what I expected it to be. I am really impressed with their team who worked closely with me to translate our vision into reality."

Abbott

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

Our Key Projects

Siemens Healthineers

Translations done on client's Medical reports related to peripheral vascular disease and hypertension.

Limbus

Translated client's equipment manual related to contouring in RT-Structure Sets and renaming partial structures according to TG263 standard.

Path

Translated the production report for Upacicalcet sodium hydrate (AJT240 Na), an active pharmaceutical ingredient.

3H Medi Solution

Translated and Transcribed, a clinical project where the client interviewed a set of patients about a particular health issue and their symptoms.

Sanofi

High-quality translations were completed on Sanofi's adverse event reports, developed by the Council for International Organizations of Medical Sciences (CIOMS).

Alvogen

Translated 121 files of Pharmaceutical and Chemical–Formulation Development and Quality Assurance–Standards and Quality Test Reports for Alvogen.

Koru

Translated catalogs for client's various medical solutions that help with treating and maintaining the skin.

Jeisyes

Translated a Clinical Research Paper related to High-Intensity focused Ultrasound that Decreases Subcutaneous Fat Tissue Thickness by Increasing Apoptosis and Autophagy.

Our Memberships

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Our ISO Certifications

As a professional translation service provider, our certifications demonstrate our commitment to clients and business partners worldwide.

Translation Services

ISO 17100:2015

Requirements For Translation Services

Information Security

ISO/IEC 27001:2022

Information Security Management System

Medical Devices

ISO 13485:2016

Medical Devices - Quality Management System

Quality Management

ISO 9001:2015

Quality Management System

Frequently Asked Questions

Certain documents require approval for implementation and communication. These documents, known as regulatory documents, are integral to the medical industry. Many countries, such as the USA and Japan, require that dossiers and approval files for new medical products be translated and submitted in multiple languages for regulatory bodies to review and analyze.

The regulatory translation process is extensive. It begins with gathering appropriate data from sources and editing this information to achieve the desired tone. After regulatory translators handle the translation of regulatory files, the text may undergo various levels of review before being presented in the local language of regulators.

To maintain clarity and consistency in regulatory translation, our subject matter experts meticulously and efficiently translate your regulatory documents. Following translation, these documents undergo a quality assessment process where other translators proofread them for errors.

Regulatory translation is a crucial process demanding accuracy and professionalism from translators. Ulatus offers highly professional subject matter experts with credible experience in delivering translations for regulatory files and documents. Our regulatory translators ensure precise translations, possessing expertise in technical language and regulatory compliance.