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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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.
Industries We Serve
![Pharmaceuticals](https://lifesciences.csoftintl.com/wp-content/uploads/2021/03/heathcare-blue.svg" "Pharmaceuticals")
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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Quality Assurance
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
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Data Security
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.