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.

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      We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.

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      Quality Assurance

      High-quality translation is extremely important in the life sciences – inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality translation and interpretation solutions for every step in the R&D and marketing process for life science companies. In order 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. In addition, we have perfected our localization best practices through linguistic validation, back translation, in-country review (ICR) and terminology management, we have the tools and team to help you reach patients globally.

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