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Melissa Leyva Email
Regulatory Affairs Scientist . RareMoon | Orphan Drug Regulatory Affairs
Baltimore, MD
Locationm******@raremoonconsulting.com
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Employees:
9Revenue:
$1.4MAbout
RareMoon Consulting is an orphan drug regulatory services firm focused on translating science into concise regulatory documents in preparation for key clinical trials both in the US and Europe. Our regulatory team brings over 100 combined years of industry and consulting experience in orphan drug regulations and development. Made up entirely of Ph.D./MS-level, senior regulatory strategists and mechanics, and all the passion in the world, they lead programs to success. Our core team backed by a nonclinical development expert (Ph.D., DABT), clinical pharmacologist (Ph.D.), pharmacometrician (Ph.D.), ex-EMA Reviewer (Ph.D.), and a publisher, offers success time and time again. Our Clients are those looking for strategic and operational support; someone who can be eyes-on and hands-on their program as and when needed; someone to help them navigate this complex regulatory pathway, and help them to decide when and how to submit their orphan applications, applications for accelerated approvals, and interact with the Agencies. They hire us to incorporate data from the smallest of populations coupled with novel therapies into the purest blend of science, regulations, patient care, and corporate objectives. We help them to maneuver the product through the regulatory framework, steering the data into a regulatory position that is poised to accelerate into marketing as early as possible. They trust our team, as we continue to work fast and hard to ensure their success. We plan, formulate questions, write, review, and/or submit.  - Regulatory operations  - Strategy & Development  - Medical Writing  - Publishing Visit our website to hear what our clients are saying about us.RareMoon | Orphan Drug Regulatory Affairs Address
8 Market PlBaltimore, MD
United States