Designed and developed around industry regulations and best practices
Regularly updated to ensure compliance with the latest authoring guidance
Cut down review times with consistent layouts and comprehensive instructional guidelines
Creating documents for electronic submissions can be a time-consuming, inconsistent process involving many different authors, working with numerous different files.
eCTDtemplates provide a simple way to create consistent and compliant dossiers in eCTD (electronic Common Technical Document) and other formats.
All eCTD dossiers start their life as a set of individual documents, authored around common structures and containing standard information. With each individual author writing in their own style, the resulting documents are often inconsistent in appearance and format. This often leads to a lengthy review, both internally and at the agencies.
Through their library of over 1300 pre-written Microsoft Word templates, eCTDtemplates deliver a common starting point for all your technical documentation. By ensuring consistent authoring standards, it enables authors to focus on content and automate the style. This reduces common errors and provides a harmonized structure for non-regulatory personnel.
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Director Business Development, Technical Operations and international Business at Genericon
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Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.