Effective June 2, 2017, Cote Orphan LLC has been purchased and is now wholly owned by QuintilesIMS. All Cote Orphan personnel (including Dr Tim Cote) are being carried forward as employees now of "Cote Orphan, a QuintilesIMS Company". We are delighted to continue serving hundreds of orphan drug innovators with the absolute best in both orphan designations and review division regulatory affairs. 


The Coté Advantage

  • As director of the OOPD at the FDA, Dr. Tim Coté personally signed off on 1,400 orphan designation applications, awarding 800 designations.
  • Oversaw the progress to full marketing approval of 150+ orphan drugs from 2007-2011.
  • Team of 25 professionals of whom more than 70% are doctoral-level trained.
  • Regulatory scientists with deep knowledge and experience in the “unwritten rules” of the FDA regarding orphan drugs.
  • Coté Orphan is the largest submitter of FDA and EMA orphan designations worldwide.
  • Coté Orphan is dedicated to providing tangible deliverables that measurably enhance our clients’ assets. We do not merely opine—we do the work of creating quality regulatory filings.