When investing in eCTD capabilities, submission document authoring is a natural starting point because good authoring standards and processes produce well-formatted, compliant documents that can be submitted and reused across multiple submissions.
Octagon’s eCTD JumpStart™ offering represents months of research, preparation and documentation of Octagon’s best practices for submission authoring. The package incorporates these best practices into documentation, tools and supporting services that will ensure your organization’s success in developing a strong eCTD foundation.
Octagon’s eCTD JumpStart offering provides standards such as document naming conventions, bookmarking and hyperlinking standards and recommended folder structures to support eCTD submission document authoring. A detailed style guide offers a consistent look and feel, ensures documents meet regulatory guidances and ultimately ensures the delivery of reviewer-friendly submission documents. One day of professional services has been included to provide assistance and guidance in developing and initiating an organizational approach to eCTD. eCTD JumpStart is the catalyst companies need to accelerate the eCTD learning curve.
Octagon’s eCTD JumpStart complements our StartingPoint® global eCTD template suite which is a collection of over 200 submission authoring templates. These templates provide content and format guidance and are the result of Octagon’s significant experience in the submission authoring process.
- Supports authoring of submission-ready documents and allows authors to focus on content rather than formatting
- Facilitates automation of publishing activities such as extraction of heading styles for bookmarks, and MS Word® cross-references for hyperlinks
- Minimizes document rework and redundancies during the submission assembly process, which reduces submission preparation timelines
- Supports a consistent corporate “look and feel” and ensures that documents meet Regulatory guidance
- Provides efficient creation, management and retrieval of submission documents, through use of the document naming conventions and recommended folder structure
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