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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 makes all the difference
REGULATORY SERVICES AND STRATEGIES
Orphan Drug
Designations
Regulatory
Strategy
Meetings with
the FDA
Orphan Drug
Designations
Regulatory
Strategy
Meetings with
the FDA
Investigational New Drug Applications
Submissions for
Expedited Programs
Other Services and Programs
Investigational New Drug Applications (IND)
Submissions for
Expedited Programs
Other Services and Programs
Only Orphans Cote LLC., an orphan drug consulting firm leverages Dr. Cote’s experience as Director, 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 sale to IQVIA. Since July 2021 this new consultancy has sprued an additional 120 clients on orphan drug regulatory matters. As both public servant and industry consultant, Dr. Cote has done the most regulatory work in orphan drugs. Let his experience work for you.
Together with our clients in North America, Europe, Asia and the Middle East, we are impacting the orphan drug market.
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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.
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