Welcome to my new blog. I’m going to use this space to post answers to questions I get from my clients and discuss issues of general interest related to implementing eCTD processes. There are many aspects of electronic submissions that simply aren’t in the guidance, or the guidance is so broad that it is open to many interpretations. I plan to use this space to try to demystify the eCTD. I really believe that eCTD is not difficult to implement, but it is new and different.