eCTD Tips is the personal blog of Evan Richardson.
I have over 10 years of experience in Regulatory Affairs and Regulatory Submissions for pharmaceutical, biologic, and medical device products. I have prepared hundreds of submissions to FDA, including work on over a dozen eCTD Investigational New Drug Applications (INDs) and six eCTD marketing applications for products which have been approved by FDA. I’ve authored articles on regulatory submissions for Ask-Cato.com , the official blog of Cato Research, PharmPro.com and The eCTD Summit, the official blog of GlobalSubmit. I am a member of the Regulatory Affairs Professionals Society, the Drug Information Association, and the North Carolina Regulatory Affairs Forum.