How to accelerate regulatory reviews with an eCTD viewer
Following another successful major filing at Boyds, the benefits of incorporating an eCTD viewer tool into the Quality Control (QC) process are once again evident. In our latest blog from the Regulatory Operations team at Boyds, we outline those advantages and explain how such investment delivers value from the initial to the final review.
What is an eCTD viewer?
An eCTD viewer is a user-friendly, integrated platform for viewing complex eCTD applications. It replaces the difficult, multi-step process of manually managing published outputs (such as copying and unzipping files) with a streamlined, web-based interface for overseeing a complete product lifecycle or individual sequences.
Headline features of an eCTD viewer
- Single-location access: Provides a single, centralised portal for viewing and navigating the entire submission, from individual sequences to the complete application lifecycle.
- Enhanced navigation: Enables quick access to the document hierarchy, ensuring efficient review.
- Supports content review: Offers tools for quickly checking document accuracy and formatting, including text searching and zooming.
- Improves QA/QC: Facilitates easy quality control of internal and external hyperlinks. Adding the ability to trace a document’s history and see its current status in a single view dramatically improves the efficiency of the review process. Reviewers no longer need to manually search through older versions to determine what has changed. The status indicators ‘New,’ ‘Replace,’ and ‘Delete’ are clearly identified.
- Eliminates inefficiencies: Removes the need to open and manage multiple files, streamlining numerous processes
- Mirrors regulatory review: Allows internal teams to see the submission exactly as an agency reviewer would.
- Collaboration: Offers real-time visibility with all teams gaining a clear, unified view of a submission’s status, versions, and content. This immediate transparency helps align everyone’s efforts and prevents miscommunication.
- Enables rapid response: Provides the fastest and most accurate way to respond to agency questions.
Looking ahead – eCTD version 4.0
Regulatory bodies adopting eCTD version 4.0 will introduce significant changes to submission requirements, particularly for viewing. This major update eliminates several core features of eCTD v3.2, including the index.xml, associated style sheet, and the traditional hierarchical structure. Given these changes, utilising a specialised eCTD viewer is essential for anyone submitting applications in the upgraded format.
Secure, supported, and scalable, the Boyds eCTD viewer is a globally trusted brand with a strong reputation among industry professionals and regulatory authorities.
To find out more about how the Boyds’ Regulatory Operations team can help you to streamline your submissions process and accelerate regulatory reviews, get in touch.