The Common Technical Document, also known as CTD and eCTD, 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, making CTD and eCTD translations essential for companies bringing new medications to market. 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, including 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. To help companies navigate this challenge, CSOFT Health Sciences’ global network and of 10,000+ native linguists and CTD and eCTD 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 and eCTD translations in over 250 languages.
Our Methodology for CTD and eCTD Translations
CSOFT Health Sciences 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 FDA, EMA, TGA, and NMPA policy reforms, as well as 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.
Learn more about our methodology.
Regulatory Compliant Formatting for CTD and eCTD Submissions
Regulatory authorities have strict requirements for CTD and eCTD submissions which also extends to language requirements. If documents are not properly formatted, pharmaceutical companies may experience delays in time to market, leading to serious revenue losses. CSOFT Health Sciences’ team of desktop publishing (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)
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.
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.