Orphan Drug Consulting Experts

Experts in delivering FDA & EMA Orphan drug designations and marketing authorization

Dr. Timothy Cote
-CEO, Only Orphans Cote

Dr. Timothy Cote is a former Director of Orphan Product Development at the FDA and an expert in orphan drug regulatory affairs and rare diseases

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.

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    Orphan Drug Regulatory Affairs Seminar: 

    Walking Your Orphan Through The FDA

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    Didn’t Meet Us at BIO JPM or Biotech Showcase 2025?

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REGULATORY SERVICES AND STRATEGIES

  • Orphan Drug Designations
  • Regulatory Strategy
  • Meetings with the FDA
  • Investigational New Drug Applications
  • Submissions for Expedited Programs
  • Other Services and Programs


Orphan Drug
Designations

Regulatory
Strategy

Meetings with
the FDA

Orphan Drug Designation

Orphan Drug
Designations

Regulatory Strategy

Regulatory
Strategy

Meeting with the FDA

Meetings with
the FDA

Investigational New Drug Applications

Submissions for

Expedited Programs

Other Services and Programs

Investigational New Drug Applications (IND)

Investigational New Drug Applications (IND)

Fast Submissions for Expedited Programs

Submissions for

Expedited Programs

Orphan Drug Designation Consulting

Grant Writing and Other Regulatory Services

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.

Orphan Drug Designation Application

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. 

World orphan drug consulting map

Meet the OOC Team at Upcoming Biotech Conferences and Events 2025

World Orphan Drug Congress 2025

April 22-24 Boston, MA


LSX World Congress USA

September 16-17 Boston, MA

ASGCT 2025

May 13-17 New Orleans, LA


RAPS Convergence

October 7-9 Pittsburgh, PA


BIO International 2025

June 16-19 Boston, MA


Bio Japan 2025

October 8-19 Yokohama, Japan


THE ORPHAN MINUTE VIDEO SERIES

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.