Prepare and submit an FDA
guidance-compliant pre-IND package
When our client's pre-IND
submission was refused by the FDA, Camargo was engaged to quickly prepare
and submit an FDA guidance-compliant pre-IND package. Camargo's team of
regulatory experts tackled the task and completed it within three weeks.
In addition to bringing top-notch medical writing, data analysis and
research skills to the project, we understand FDA reviewers'
requirements and the appropriate methodologies for each type of
Thanks to FDA acceptance of the
pre-IND package prepared by Camargo, our client was able to proceed
expeditiously with drug development. Meanwhile, in the course of reviewing
the documents, Camargo had discovered that several clinical studies
included in the proposed IND budget were redundant and unnecessary.
Elimination of these studies resulted in savings for our client of