CTD/eCTD Submissions

Regulatory authorities have strict requirements for CTD and eCTD submissions. If documents are not properly formatted, pharmaceutical companies may experience delays in time to market, leading to serious revenue losses. CSOFT’s team of DTP engineers provide regulatory compliant formatting support to ensure on-time submission for the best ROI for pharmaceutical companies.

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    Home 9 CTD/eCTD Translations Services

    CSOFT’s team of subject matter expert linguists have a minimum of five years of experience in the field to meet your medical translation needs, whether it’s for healthcare reports, medical device manuals, clinical trial translations, patient informed consent forms, or whatever medical content you need translated. We offer our medical translation solutions in over 250 languages, and our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.

    As the demand for pharmaceutical products shifts overseas, the need for CTD and eCTD translations are growing. Because CTDs and eCTDs are highly specialized documents with high volume and tight deadlines, finding the right partner to translate them accurately and efficiently is vital. Mistakes in translation, incorrect formatting, or missed deadlines can increase time to market, potentially costing pharmaceutical companies millions in lost revenue. CSOFT’s global network and of 10,000 native linguists, CTD subject matter experts with familiarity in all modules (including CMC, PK/PD, Toxicology, Clinical Written, and Tabulated Summaries), CTD formatting services, and technology driven systems provides life science companies with highly accurate and time-efficient CTD/eCTD translations in over 250 languages.

    Medical Device Translation

    In cardiology, medical devices, such as implantable cardioverter defibrillators (ICD), ventricular assist devices (VADs), biventricular pacemakers, pacemakers, implantable cardiac loop recorders, automated external defibrillators (AED), and stents are used to treat a wide variety of cardiovascular diseases. For medical device manufacturers to be competitive in foreign markets and prevent unnecessary patient deaths, medical device documentation such as instructions for use (IFU) and package inserts and labels must be translated accurately and with fast turnaround times. With a global network of 10,000 in-country linguists and subject matter experts (SMEs), CSOFT can provide medical device manufacturers with highly accurate and timely medical device translation services.

    Learn more about our medical device translation.

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      Quality Assurance

      High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015,ISO 9001:2015, and ISO 13485:2016 certified quality management system.

      Learn more about our quality assurance process.

      High Quality Academic Translations
      ISO-certified Academic Translations

      Data Security

      CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and  ISO 17100:2015, and leverage best practices from ISO 27001.

      Learn more about how CSOFT protects companies’ data.