Overview

Specializing in Orphan Drug, Pediatric Rare Disease, Fast Track, and Breakthrough designations In the first seven months after we opened our doors in May of 2016, KLA Scientific Consulting played a critical role in over 35 submissions to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 18 FDA Orphan Drug Submissions 8 FDA Pediatric Rare Disease Submissions 5 EMA Orphan Drug Submissions 4 FDA Fast Track Submissions 3 FDA Breakthrough Submissions 1 FDA Pre-submission Meeting 1 EMA Pre-submission Meeting We also offer feasibility studies and strategic reviews.