Effective June 2, 2017, Cote Orphan LLC has been purchased and is now wholly owned by QuintilesIMS. Cote Orphan personnel 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

  • 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.