RareMoon Consulting, Inc.
RareMoon Consulting (RMC) is a premier regulatory affairs consultancy specializing in orphan drugs and advanced therapies. RMC’s team of 17 Ph.D./MD/MS-level experts brings over 300 combined years of industry, regulatory agency, and consulting experience. Our multidisciplinary team includes specialists in clinical, nonclinical, and chemistry, manufacturing, and controls (CMC), as well as senior regulatory strategists, operational leaders, and publishing experts—all dedicated to guiding programs from early preclinical development through approval.
Under the leadership of Co-founders Sabrina Mogle and Chris Novashinski, RMC has been a trusted partner for over 200 Sponsors, successfully leading hundreds of projects to completion and supporting over 400 unique assets, including more than 150 gene and cell therapy programs. Our expertise spans rare genetic, dermatological, and ophthalmic diseases, pediatric diseases, oncology, autoimmune, and medical countermeasures, ensuring that groundbreaking therapies reach patients in need. (Updated December 2024)
RMC provides strategic and operational regulatory support, leveraging our deep experience to navigate complex regulatory pathways. We guide critical decisions on global regulatory plans, orphan drug designations, expedited program applications, accelerated approval pathways, and regulatory agency interactions, ensuring a clear and efficient path to approval.
