Coté Orphan is a boutique full-service regulatory group with a laser focus on Orphan Drugs. From the lab to the market, we take you and your idea to the FDA and EMA for approval. With over 300 innovative biotechnology and pharmaceutical clients, Team Coté is led by Dr. Tim Coté, the former Director of the FDA's Office of Orphan Products Development (OOPD).


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.