Module 3 is usually the most complicated part of an eCTD submission for Regulatory Operations. It contains a lot of complex documents, and small companies that may have a medical writing group usually don’t have a similar group for CMC documents. Finalizing CMC documents is often very challenging due to the nature of the documents themselves and the number of parties who have to sign off. Regulatory Operations groups can take a few steps to increase the predictability of this effort, as outlined below.
Tag Archive: Authoring
Module 3 Project Management
Too Many Hyperlinks!
Most eCTD publishing systems now come with tools to simplify the process of inserting and updating cross-document hyperlinks. These tools generally work well, save time, and enable publishers to incorporate late content changes without having to redo all their links.
So what’s the problem?
Did you ever get lost in a book with too many footnotes?