Raremoon | Orphan Product Development

Description

• RareMoon Consulting is an orphan products services firm focused on translating science into concise regulatory documents in preparation for key clinical trials both in the US and Europe. We are a team of highly trained Regulatory Scientists & Nonclinical Experts who know when and how to navigate the Agencies. We work with your team to build targeted US/EU Product Development Plans, execute successful Product Applications and offer efficient, strategic advice. Our team is made up seasoned Regulatory Affairs, Nonclinical, BioAnalytical, and Clinical Experts who maintain up-to-date knowledge of the industrys fast-changing landscape. Each expert consultant is carefully selected for your project, ensuring alignment with your program needs. We have a proven track record of navigating the Agencies and driving successful programs to pivotal milestones, benefiting Patients and Stakeholders. More than 100 combined years of Industry, CRO, and Consulting experience Over 25 years in the rare disease sector Attended more than 25 FDA and EMA Agency Meetings 7 successful New Drug Applications 4 successful Biologic License Applications 43 successful INDs 65+ supporting applications including US/EU orphan drug designations, Breakthroughs and Fast Tracks Are you in need of an an expert to assist you with building a Product Development Plan or undergoing an IND gap analysis? Are you looking for external writing and publishing support? Reach out & have a conversation. Whether or not we decide to do business together, We are confident our call will be insightful and provide ideas to help you achieve your goals. For more information please contact Sabrina at sabrina@raremoonconsulting.com.
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  Headquarters:8 Market Place , Baltimore, Maryland, United States

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  Phone Number: +1 443-243-8733

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  Website: https://www.raremoonconsulting.com

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  Employees:5

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  Revenue:$1 - 10M

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  Legal Name:Raremoon | Orphan Product Development

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• |  NAICS Code: 541320  |

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