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.
INDs
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.