eCTD submission services
The electronic publishing process leading to a regulatory submission may be divided into five processes:
- Document/report level publishing
- Regulatory submission level publishing
- Fit and finish activities
- Document and submission quality control
- Submission of the published package to the health authority via an electronic portal and archival of the document, including healthy authority correspondence
Our services for document/report level publishing include:
- Scanning paper content
- Converting documents into PDFs according to regulatory guidance
- Creating bookmarks matching table of contents
- Creating a hyperlinked table of contents
- Hyperlinking internal and external documents
- Ensuring that documents are well-formatted, complete, and legible (pertinent to old legacy reports)
- Quality control on all document navigation
- Resolve publishing errors
- Converting legacy paper-based submissions to eCTD
- Creating baseline submissions
- Quick turnaround on responses to queries to reduce overall approval time
- Provide regulatory and strategic advice for managing the lifecycle of registered products as per market regulations
- Customized Quality Control checklist for each submission type