The Common Technical Document, also known as CTD, is a collection of information about a drug’s (Pharmacology and Toxicology) overall quality, toxicology, and safety and efficacy that is submitted to regulatory authorities such as the FDA, EMA, NMPA, and Health Canada when compiling applications for new drugs. As the world becomes increasingly digital, the electronic Common Technical Document, or eCTD, has emerged as a way to pursue harmonization in electronic submissions of the CTD. Both the CTD and eCTD are composed of five modules. While Module 1 is technically region-specific and not an official part of the CTD, Modules 2, 3,4, and 5 cover a summary of Modules 3-5, clinical quality, toxicology and pharmacology reports, and clinical trials.
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.
CSOFT International has a 10,000+ strong network of industry experienced linguists, professional in-country reviewers, cultural experts, and DTP engineers that are ready to deliver localization solutions for regulatory submissions at any time. CSOFT is specialized in CTD translation projects. Our professional team has in-depth knowledge of recent NMPA policy reforms and regulatory requirements. In addition, we have a stringent quality control methodology for dossier translations designed for helping global drug developers mitigate risk while seeking approval from global regulatory bodies.
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Regulatory Compliant Formatting for CTD and 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. Specifically, CSOFT’s team of DTP engineers can provide the following formatting services for CTD and eCTD submissions:
- Hypertext, index, and bookmark creation to ensure document cross-references
- Internal hyperlinking – sections, tables, figures, references, and appendices
- Table of contents – overall, tables, figures, and appendices
- Embedded fonts
- Consistent headers/footers and page orientation
- Converting PDF documents into MS Word files through OCR (Optical Character Recognition)
Professional, high-quality translation is essential for successful CTD and eCTD submissions. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance special to the life sciences that includes linguistic validation to ensure that any project that is translated meets quality standards in a timely manner that is also cost-effective. Our advanced translation technology management system allows for translation projects remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 9001:2015 and ISO 13485:2016 and our operations are compliant with ISO 17100 to ensure our customized solutions meet regulatory requirements.
CSOFT has implemented many security procedures throughout our organization to ensure client proprietary information is always held in the highest confidence. 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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