The Orphan Opportunity Video Series

The pre-IND Meeting

Breakthrough Therapy Designation

Priority Review Vouchers

Medically Relevant Subsets vs. Salami Slicing

When is the Same Orphan Different?

When to Apply for Orphan Designation

Introduction to the Orphan Drug Regulatory Landscape

About Us

Coté Orphan Consulting is a regulatory affairs advisory firm passionate about bringing miraculous new drugs for rare diseases to the people who so desperately need them. Having provided successful regulatory outcomes to some of the most notable names in the industry, COC knows the FDA hurdles unique to orphan products and forges successful pathways to orphan product designation.

Conferences
- RAPS 2014
  
  Starts: September 27, 2014
  
  Ends: October 2, 2014
  
  Location: Austin, TX, United States
- Bio-Europe Fall 2014
  
  Starts: November 3, 2014
  
  Ends: November 6, 2014
  
  Location: Frankfurt, Germany
- World Orphan Drug Congress - Europe
  
  Starts: November 12, 2014
  
  Ends: November 15, 2014
  
  Location: Brussels, Belgium