Only Orphans Cote

Delivering drugs through FDA and EMA

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Orphan Drug Designations

Our flagship product. We write orphan drug designation (ODD) applications for both the FDA and EMA. With an ODD, the sponsor may receive economic benefits designed to support their drug development process and commercialization.

Regulatory Strategy

No matter where you are in your orphan drug development lifecycle, we can assess your program and bring a solid regulatory strategy to help expedite achieving your goals and ensure you are using all the regulatory perks at your disposal.

Meetings with the FDA
(Interact, pre-IND, Type A, B, C)

From the pre-IND meeting to the pre-NDA/-BLA, you will meet with the Agency to gain insight into their thinking into your drug development. We know how to optimize these meetings so that you can get your questions answered and get the most out of the FDA to help expedite your program.


Prior to first-in-human studies, you must file an IND with FDA to demonstrate that it is safe to use your drug. After being informed by a pre-IND meeting, we will go through your data and write your IND for submission to the Agency.

Submissions for Expedited Programs

o Breakthrough Therapy
o Fast Track
o Accelerated Approval
o Priority Review

Additional Services and Programs

o Qualified Infectious Disease Program (QIDP) Designation
o 505(b)(2)

Our Objectives

Crystalize our clients’ drug development work into regulatory tangibles. In doing so, we enhance asset valuation, investment attractiveness and exit options.

Led by Dr. Tim Cote, the former Director of the FDA Office of Orphan Products Development (OOPD), and a dedicated staff including a former FDA OOPD reviewer, Only Orphans Cote provides unmatched regulatory service that will get your orphan drug to market.

Only Orphans Cote LLC is a regulatory affairs consulting firm leveraging its expertise and commitment to delivering drugs for rare diseases.  

Our Founder and Principal, Dr. Tim Cote is re-engaging with the biotech and pharmaceutical industry after a 4-year non-compete hiatus that was agreed with IQVIA as part of their acquisition of his first-found consultancy in 2017. Driven by the success of his initial experience through its 5-year journey of explosive growth, Dr. Cote’s strategy, this time round, is to identify potential winners to offer the appropriate advice and support that can complement a strong track record of drug delivery to market.

Get in touch with Only Orphans Cote


About Dr. Tim Cote

Founder and CEO • Only Orphans Cote LLC • (June 2021- Present)
Orphan drug regulatory affairs consultancy that exclusively works with anything related to orphan products.

Founder and CEO • Silk Road Therapies LLC • (March 2018- Present).
Founded a biotech to create a new therapy for Behcet’s Disease; formulated product and conducted highly successful 41-person Phase 2 trial under FDA IND in Istanbul, Turkey; secured FDA orphan drug designation, fast track status, and conducted numerous FDA regulatory meetings

Founder and CEO • Coté Orphan, LLC • (May 2012 -June 2017).
Established sole-ownership, boutique consultancy in orphan drug regulatory affairs; Provided services in orphan product regulatory affairs for start-ups, biotech, large pharma; grew business to $7MM annual revenues, 450 clients; business acquired by IQVIA

Director • Office of Orphan Products Development, FDA•(September 2007-June 2011)
▪ Implemented the Orphan Drug Act (designed to create therapies for the estimated 8,000+ rare diseases)
▪ Led Congressional briefings on behalf of his office, administered a budget of $18M and supervised 45 professionals
▪ Formal representative of FDA in meetings with European regulatory agencies responsible for orphan drugs.
▪ Speaking engagements to multinational pharmaceutical industry, patient advocacy groups, and academic innovators
▪ Responsible for final decisions related to 1,400 applications for orphan drugs eligible for economic benefits of orphan designation
▪ Welcomed 200 new orphan drug marketing organizations
▪ Oversaw grants awards, management processes and human subject’s protection efforts
▪ Developed new initiative for the development of therapies for neglected tropical diseases.

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+1 617-852-6416
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