Regulatory Documents Translation


Precision in Compliance

At Translate.One, we provide extensive regulatory translation solutions designed to streamline the international compliance process, facilitating accurate and timely submissions. Our clients trust us for our regulatory expertise and ISO-certified processes, as we ensure translations that are not only linguistically precise but also align with local and cultural requirements seamlessly.

With over 25 years of experience, we have been a reliable partner to global pharma, medical device, biotechnology, CRO, and healthcare organizations, helping them overcome regulatory obstacles. We specialize in preparing documentation for various governing bodies worldwide, including but not limited to the FDA, EMA, CFDA, SFDA, and PMDA.

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We Handle a Broad Range of Regulatory Documents

Our specialization extends across various domains within the medical industry, including:

  • Instructions for Use (IFUs)
  • Investigator’s Brochures (IBs)
  • Labeling
  • New Drug Application (NDA) or Marketing Authorization Application (MAA)
  • Package Information Leaflets (PILs)
  • Summary of Product Characteristics (SmPC)
  • Common Technical Documents (CTD)
  • Technical File (TF) or Design Dossier (DD)
  • Clinical Study Reports (CSRs)
  • 510(k) Submission
  • Premarket Approval (PMA) Application
  • Post-Market Surveillance (PMS) and Vigilance Reports
  • Quality Management System (QMS) Documentation
  • Dossiers
  • Validation Documents
  • Chemistry, Manufacturing & Control Documentation (CMC)

What Makes Our Services Stand Out

Why Us?

  • Industry-Compliant Translations

    We understand that each sector has its unique set of regulatory challenges. Our linguists not only master multiple languages but are also well-versed in industry-specific regulations, ensuring compliance on a global scale.

  • ISO Certified Processes

    We are proud to uphold ISO 9001, 17100, and 13485 certifications, reflecting our commitment to quality, customer satisfaction, and adherence to the highest standards in translation services.

  • Confidentiality and Data Security

    Your regulatory documents are sensitive, and we treat them with the utmost confidentiality. Our secure ISO 27001 certified systems and our adherence to data protection protocols provide you with peace of mind.

  • Insights

  • Translate.One Acquires Enable2

    Translate.One Acquires Enable2, Enhancing Language Support Services Globally

    ATLANTA, GEORGIA, UNITED STATES – June 10, 2024 - Translate.One, a distinguished…

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  • Translate.One Announces Rebranding of Commit Global, inWhatLanguage, and Balthasar Ltd.

    Translate.One Announces Rebranding of Commit Global, inWhatLanguage, and Balthasar Ltd. 

    ATLANTA, GEORGIA, UNITED STATES, May 15, 2024 – Translate.One, a distinguished global…

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  • Translate.One Honored as Silver Stevie® Award Winner in 2024 American Business Awards®

    ATLANTA, GEORGIA, UNITED STATES– April 26, 2024 – Translate.One is proud to…

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  • Testimonials

    What Our Clients Have to Say

    At Translate.One, our clients’ satisfaction is our utmost priority. We take pride in delivering exceptional translation services that exceed expectations. But don’t just take our word for it – hear what our clients have to say.

      Great professionalism and communication!

      Marketing and Advertising Company

      I’ve been utilizing Translate.One for translation services for almost 5 years and have had nothing but positive experiences. They’ve always surprised me with their swift response time, and have saved me on more than a few occasions when I needed to turn something around quickly. They have proven to be a reliable and valuable supplier partner. Highly recommend!

      Medical Device Company

      We rely on Translate.One to provide high quality translation services in more than 10 languages. They are always deliver on time and on budget.

      Software Company

      Work of high quality, even with terminology terms, responsibility towards deadlines, project manager understands the needs of the client.

      Consulting Firm

      The right partner for medical technical translation services.

      Medical Equipment Company

      A reliable, fast and responsive company!

      Consultancy Firm

      Outstanding service from start to finish! We really felt like your team put a lot of consideration and time into the project – our best interest was always kept in mind. Completion time frames were always as promised.

      Wellness Company

      Translate.One’s delivery of localization services is simply outstanding – from document/website conversion, on-site subject matter experts and voice-over talent they really offer a broad range of services to support our worldwide customer base.

      Technology Company

      We had an awesome experience with the whole team. Everyone was really easy to work with and they delivered a high-quality translation in a record time. I particularly enjoyed their extreme attention to detail.

      Video Production Company

      The translations I have received from Trustpoint.One, now Translate.One, are always reliable, competitively priced and delivered on time. The project manager that I work with is always attentive and responsive.

      Plastics, Glass and Aluminum Manufacturer

      I run a nationwide immigration practice. I have critical documents coming in from all over the world in all sorts of languages. In my business you need quick efficient and accurate translations. Translate.One. aka Trustpoint.One has never let me down.

      National Immigration Group

      I always rely on Translate.One as my final proofread/edit of TEQ magazine. I sleep better with an independent set of eyes on TEQ before I go to press. I’m always impressed with the speed and quality of work.

      Pittsburgh Technology Council

    Book a Meeting, Request a Quote or More Info!

    Translate.One is a B2B company and unable to offer help with personal documents.

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