The electronic Common Technical Document (eCTD) format is the standard submission format for master files and also the format designated by US FDA and Health Canada for the submission of master files such as DMF and ASMF. Submission of a US or EU DMF registration requires the preparation of eCTD documents and we can assist companies in preparing documents to obtain DMF registration codes. eCTD offers many advantages over traditional registration submissions, especially in terms of the creation, review, archiving, retrieval, reuse, and management of registration documents. eCTD improves efficiency, reduces costs, and adds convenience for both pharmaceutical companies and regulatory agencies.
With China joining the ICH, successive eCTD policies have been introduced that have accelerated the utilization of eCTD in the country. The market demand for eCTD translation has also witnessed rapid growth. However, both CTD and eCTD are large-volume, highly specialized documents with tight submission deadlines, and pharmaceutical companies need reliable partners like EC Innovations to provide accurate and professional translation services. EC Innovations’ life sciences business unit is composed of experienced professional translators and industry subject matter experts (SMEs) and provides life science companies with CTD and eCTD translation and submission solutions in more than 140 languages.
eCTD Submission Service
In addition to high-quality translation, ECI also provides eCTD file preparation services where a complete set of documents is provided in the eCTD directory structure ready for submission by the customer. Our professional DTP team provides regulatory-compliant formatting support to ensure your eCTD files are submitted on time. Formatting support includes:
- Bookmarks, links, hypertext
- Word file style adjustments
- Table of contents, tables, figures, appendices, etc.
- Embedded fonts
eCTD Quality Assurance
Expert team leaders
Our project managers are experts with more than ten years of experience in eCTD document production who take full charge of the coordination of the project.
Four-eyes principle
Working in teams of two, each translator has a designated QC supervisor with internal four-eyes checks carried out.
Management system
We have clear execution standards, well-defined acceptance criteria, and transparent reward and penalization policies.
Final inspection and review
The project manager conducts a final inspection and review before delivery and signs off on the release.
Information Security
We are deeply aware of the importance of confidentiality and do our utmost to ensure the security, confidentiality, and integrity of customer documents and communications.
- Project documents are protected by adhering to strict procedures and guidelines throughout the project process.
- All project personnel are required to sign a non-disclosure agreement.
- We have passed all customer security audits, including global audits by multinational corporations.
- We have achieved ISO 27001 information security management system certification.
- Multiple data encryption technologies are adopted when transmitting data.
- Reliable backup, disaster recovery, and data recovery mechanisms in place.
We appreciate your interest in EC Innovations.
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