You need to look at the guidance that was finalized in 2013 and there are many things that we lay out in here as to when you need to do and there is a road map to what are the requirements of the FDA and you need to consider when you are putting a submission together. Lots of p...
Request for Designation submissions (for combination products) Authorship of all sections of IND Submissions and support the submission process Authorship of IMPDs and CTA for submission to European regulators Preparation for, and attendance at, Type A, B and C meetings with FDA, and the equivalent...