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. It’s hard to give up familiar systems and processes for something new, even if you know that the change will be beneficial. I hope that this blog will help people embrace the eCTD so that they can reap the many benefits that come from electronic submissions.

I decided to call the blog The Eagle’s Nest, because as I am writing this, I’m watching the eagles fly back and forth with large sticks to rebuild their nest. Their nest will get huge over time, but they build it up one stick at a time. I hope to build this site over time so that it provides valuable insight to people on their own journeys to eCTD.