Get in touch
(617) 851-8724
Orphan Drug Consulting Experts
Experts in delivering FDA & EMA Orphan drug designations and marketing authorization
Dr. Timothy Cote
-CEO, Only Orphans Cote
Rare Diseases and Orphan Drugs Focus
Our team is ready to win for you. From data assessment to FDA/EMA submissions we have the expertise you need to get your application approved. Rare diseases deserve attention. Our unmatched regulatory services make all the difference.
REGULATORY SERVICES AND STRATEGIES
OUR COMMITMENT
Only Orphans Cote, LLC is an orphan drug consulting firm which leverages Dr. Cote’s experience as a prior Director of the FDA OOPD. Get the inside track from the man who ran the FDA’s Office of Orphan Product Development.
While at the helm, Dr. Cote personally decided on 1400 orphan designation applications and saw 200 orphan drugs go to market. His first consultancy (2012-2017) serviced about 500 clients before its sale to IQVIA. Since July 2021 this new consultancy has spurred an additional 120 clients on orphan drug regulatory matters. As both public servant and industry consultant, Dr. Cote has unique and substantive expertise with regulatory work in orphan drugs. Let his experience work for you.
OUR REGULATORY AFFAIRS GLOBAL IMPACT
Together with our clients in North America, Europe, Asia and the Middle East, we are impacting the orphan drug market.
Meet the OOC Team at Upcoming Biotech Conferences and Events 2025
Bio JPM & Biotech Showcase 2025
January 13-16 San Francisco, CA
MDUK Oxford Neuromuscular Centre Seminar
January 21 Oxford, UK
Phacilitate Advanced Therapies Week 2025
January 20-23 Dallas, Texas
Bio China 2025
March 13-15 Suzhou, China
Bio Europe Spring 2025
March 17-19 Milan, Italy
World Orphan Drug Congress 2025
April 22-24 Boston, MA
Bio Korea 2025
May 7-9 Seoul, Korea
ASGCT 2025
May 13-17 New Orleans, LA
BIO International 2025
June 16-19 Boston, MA
Medical Rationale Criteria
What is needed for orphan drug designation? Meeting the Medical Rationale Criteria is key! Dr. Cote breaks down the benchmark elements
Prevalence criteria
The Prevalence Criteria is a quantitative story. There is no list, you have to make it up! Dr. Cote tells you how to do so accurately in this orphan minute.
PRV
How can you be eligible for a PRV? Dr. Cote is here for your orphan minute to give you the inside scoop on how producing Medical Countermeasures are one way that lead to the PRV.
Orphan Exclusivity
What is orphan exclusivity? What are the guidelines for it? Dr. Cote details the rules and structure in this orphan minute.
