RareMoon Consulting
RareMoon Consulting is a private regulatory services firm that provides orphan drug and advanced therapy regulatory affairs consulting — including FDA/EMA submissions, expedited designations, and fractional regulatory leadership — to biotech and rare disease sponsors, founded in 2016 and headquartered in Washington D.C.
- Company typePrivate
- Founded2016
- HeadquartersBaltimore, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What RareMoon Consulting does
RareMoon Consulting is a private regulatory services firm founded in 2016 that provides specialized regulatory affairs consulting to life science and rare disease companies developing orphan drugs, cell therapies, gene therapies, and other advanced therapeutic products. The firm operates from a Washington D.C. headquarters with international subsidiaries in London (RareMoon Consulting LTD) and Barcelona (RareMoon Consulting ESP S.L), enabling multi-jurisdictional delivery across FDA, EMA, Health Canada, and global health agencies. The company does not develop proprietary technology products; instead, its offering is built on deep human expertise, with a team that includes former FDA reviewers from the Office of Therapeutic Products and a former EMA PDCO PIP expert, supporting sponsors across IND/CTA/NDA/BLA preparation, expedited designation strategy (Orphan Drug, RMAT, Breakthrough Therapy, Fast Track, Rare Pediatric Disease, PRIME), health agency meeting preparation, regulatory publishing, and fractional regulatory leadership engagements.
The company's service portfolio spans fractional regulatory services, gene and cell therapy consulting, regulatory filings and operations, orphan drug designations, regulatory designations, health agency meetings, and publishing/submissions management. As of June 2025, RareMoon reported 250+ FDA and EMA Orphan Drug Designations secured, 100+ Rare Pediatric Disease Designations (over 20% of all FDA RPD designations), 40+ Fast Track/Breakthrough/RMAT designations, and 400+ unique assets supported, with a 100% RMAT success rate since supporting the first FDA RMAT ever granted in 2017.
Revenue is generated through professional services engagements (project-based and multi-year fractional leadership contracts) on a quote-based pricing model that is not publicly disclosed. The go-to-market motion is enterprise-focused and event-driven, anchored by 40-50 strategic meetings annually at the J.P. Morgan Healthcare Conference, supplemented by ASGCT Annual Meeting presence, the quarterly IMPACT newsletter, and direct referrals. The firm is bootstrapped and founder-led by co-founders Sabrina Mogle (CEO) and Christopher Novashinski (COO), with no disclosed external institutional investment, no parent company, and no acquisition history to date. In May 2026, RareMoon announced a strategic partnership with Franklin Biolabs to offer integrated preclinical-to-clinical consulting packages.
RareMoon Consulting firmographics
Firmographics- Name
- RareMoon Consulting
- Legal name
- RareMoon Consulting, Inc.
- Website
- https://raremoonconsulting.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- RareMoon Consulting is a private regulatory services firm that provides orphan drug and advanced therapy regulatory affairs consulting — including FDA/EMA submissions, expedited designations, and fractional regulatory leadership — to biotech and rare disease sponsors, founded in 2016 and headquartered in Washington D.C.
- Ownership category
- akta.pro rank
RareMoon Consulting industry classification
Industry- Product category
- Pharmaceutical Regulatory Affairs Consulting
- NAICS
- Other Management Consulting Services (541618), Other Scientific and Technical Consulting Services (54169), All Other Professional, Scientific, and Technical Services (541990)
- SIC
- Services-Management Consulting Services (8742), Services-Misc Health & Allied Services, Nec (8090)
- akta.pro primary industry
- Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN)
- akta.pro secondary industry
- Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA)
Keywords
Where RareMoon Consulting is headquartered
LocationHeadquarters
- HQ city
- Baltimore
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
RareMoon Consulting business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Marketing or Sales, Operations, Infrastructure, Technology or R&D
Revenue model
- Regulatory Consulting Services: RareMoon generates revenue through professional services engagements including regulatory strategy, FDA/EMA submissions, designation requests (Orphan Drug, RMAT, Breakthrough Therapy), and agency meeting preparation. Services are delivered through fractional regulatory leadership, project-based consulting, and end-to-end regulatory operations support.
- Fractional Regulatory Leadership: Provides senior-level regulatory leadership (Fractional Head of Regulatory) to biotech companies without full-time hiring needs. This subscription-style engagement model offers flexible, ongoing regulatory guidance and execution support, backed by a team of multi-disciplinary specialists.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Quote-based professional services engagement |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
RareMoon Consulting product offering
Product offeringCore offering
RareMoon Consulting provides regulatory affairs consulting services for life science and rare disease companies developing orphan drugs and advanced therapies. Its core offerings include fractional regulatory leadership, regulatory strategy, FDA/EMA/global submissions (IND, CTA, NDA, BLA), orphan drug and expedited program designations (RMAT, Breakthrough Therapy, Fast Track, Rare Pediatric Disease, PRIME), health agency meeting support, and end-to-end regulatory operations and publishing. All services are delivered through expert consulting engagements rather than a software platform.
Product overview
RareMoon Consulting is a regulatory services firm offering a comprehensive portfolio of consulting services for life science and rare disease companies. The core offering centers on regulatory affairs expertise for small molecules, biologics, and advanced therapeutic products including cell and gene therapies. Key services include Fractional Regulatory Services (senior regulatory leadership), Gene Therapy Consulting, Regulatory Filings & Operations (IND/CTA/BLA/NDA submissions), Orphan Drug Designations, Regulatory Designations (RMAT, Breakthrough Therapy, Fast Track, PRIME), Health Agency Meetings, and Publishing & Submissions. The firm provides end-to-end support across FDA, EMA, Health Canada, and global health agencies, with specialized expertise in FDA Rare Pediatric Disease designations. RareMoon does not offer a software platform or technology product; all services are delivered through expert consulting engagements.
Differentiator
Problem solved
Functional benefit
Products and services
- Fractional Regulatory Services Provides senior-level regulatory leadership and real-time regulatory advisement to biotech and pharmaceutical sponsors developing orphan drugs and advanced therapies without the cost of full-time hires.
- Gene Therapy Consulting Regulatory and development strategy for cell and gene therapy programs, including AAV, CAR-T, CRISPR, epigenetic platforms, and other regenerative medicine products.
- Regulatory Filings & Operations Strategic preparation and execution of IND, CTA, NDA, BLA, and global regulatory submissions to FDA, EMA, Health Canada, and EU national agencies.
- Orphan Drug Designations End-to-end support for securing FDA and EMA Orphan Drug Designations, including eligibility assessment, authoring, quality review, and submission management.
- Regulatory Designations Strategic support for expedited FDA and EMA designations including RMAT, Breakthrough Therapy, Fast Track, Priority Review, Rare Pediatric Disease, and PRIME, including eligibility, authoring, submission, and post-designation planning.
- Health Agency Meetings End-to-end support for FDA, EMA, Health Canada, and global health agency meetings including INTERACT, Pre-IND, End-of-Phase, and Scientific Advice sessions.
- Publishing & Submissions End-to-end regulatory publishing and submission management including eCTD formatting, quality control, regulatory project management, SME applications for EMA, and US Agent/EU Sponsor services.
Quantifiable outcome
- 100% RMAT success rate since supporting the first RMAT ever granted by FDA in 2017
- +4 more outcomes
Companies that use RareMoon Consulting
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles3 records
RareMoon Consulting technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
RareMoon Consulting partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Franklin BiolabscoreRareMoon Consulting and Franklin Biolabs announced a strategic partnership in May 2026 to offer integrated consulting packages supporting preclinical-to-clinical development transitions. Franklin Biolabs is a preclinical contract research organization specializing in genetic medicine and biologics. The collaboration aims to help sponsors design development programs that align with regulatory expectations, reduce development risk, prevent delays, and accelerate timelines by avoiding unnecessary studies. Both companies will discuss the partnership at the ASGCT Annual Meeting in Boston, May 12-14, 2026.
Scale indicators5 records
Recent moves7 records
Expansion highlights5 records
RareMoon Consulting competitors and assessment
Company assessmentDirect peers
- ProPharma Group: Regulatory, compliance, and medical affairs consulting firm serving pharma, biotech, and medical device clients. Comparable to RareMoon in providing regulatory strategy and submission support, with broader compliance offerings.
- NDA Group: Regulatory and HTA consulting firm with strong FDA and EMA capabilities serving pharma and biotech clients. Comparable to RareMoon's transatlantic regulatory practice and orphan drug expertise.
- Halloran Consulting Group: Regulatory and quality consulting firm serving life sciences companies across development phases. Comparable to RareMoon in offering regulatory strategy, submissions support, and quality services to biotech and pharma sponsors.
- Biologics Consulting Group: Regulatory consulting firm specializing in biologics, vaccines, and advanced therapies with deep FDA CBER expertise. Closely comparable to RareMoon's advanced therapy and gene therapy consulting practice.
- Bionical Emas: Regulatory and medical affairs consultancy serving biotech and pharma with expertise across rare disease and advanced therapies. Comparable to RareMoon in regulatory strategy and orphan drug submissions support.
- Camargo Pharmaceutical Services: Specialized regulatory consulting firm with deep orphan drug, 505(b)(2), and complex generics expertise. Highly comparable to RareMoon as a niche consultancy serving small and mid-cap pharma sponsors on regulatory strategy and FDA interactions.
- Voisin Consulting Life Sciences (VCLS): Global regulatory and HTA consulting firm serving biotech and pharma with FDA, EMA, and international submission expertise. Comparable to RareMoon in regulatory strategy and orphan drug focus, with a broader global footprint.
Broad incumbents
- IQVIA: World's largest CRO with extensive regulatory consulting capabilities spanning small molecules, biologics, and advanced therapies. Represents scale competition to boutique regulatory consultancies like RareMoon.
- Parexel International: Large global CRO offering regulatory consulting, clinical development, and commercialization services across all therapeutic areas. Represents the broad incumbent alternative to boutique firms like RareMoon, with bundled service offerings.
- PharmaLex (a Cencora company): Global regulatory and pharmacovigilance consulting firm now part of Cencora, offering FDA, EMA, and global submission services. Comparable to RareMoon in regulatory strategy with much broader geographic and therapeutic coverage.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
RareMoon Consulting social profiles
Digital presenceRareMoon Consulting financial estimates
Financial estimateRevenue estimate
Valuation estimate
RareMoon Consulting leadership team
Management profileNumber of profiles
Profiles9 records
RareMoon Consulting funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
RareMoon Consulting M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about RareMoon Consulting
What does RareMoon Consulting do?
RareMoon Consulting provides regulatory affairs consulting services for life science and rare disease companies developing orphan drugs and advanced therapies. Its core offerings include fractional regulatory leadership, regulatory strategy, FDA/EMA/global submissions (IND, CTA, NDA, BLA), orphan drug and expedited program designations (RMAT, Breakthrough Therapy, Fast Track, Rare Pediatric Disease, PRIME), health agency meeting support, and end-to-end regulatory operations and publishing. All services are delivered through expert consulting engagements rather than a software platform.
Is RareMoon Consulting a public or private company?
RareMoon Consulting is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was RareMoon Consulting founded?
RareMoon Consulting was founded in 2016. It employs 1 to 10 people.
Where is RareMoon Consulting based?
RareMoon Consulting is headquartered in Baltimore, United States, in the North America region.
How does RareMoon Consulting make money?
Two revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are fractional Regulatory Leadership.
Who are RareMoon Consulting's main competitors?
Direct peers on record are ProPharma Group, NDA Group, Halloran Consulting Group, Biologics Consulting Group, Bionical Emas, Camargo Pharmaceutical Services and Voisin Consulting Life Sciences (VCLS). Broad incumbents are IQVIA, Parexel International and PharmaLex (a Cencora company).
Does RareMoon Consulting have an API?
No public API is recorded for RareMoon Consulting.
What industry is RareMoon Consulting in?
RareMoon Consulting's product category is Pharmaceutical Regulatory Affairs Consulting. Its primary akta.pro industry code is HLAIAIAN, Rare Pediatric & Congenital Disorder Therapies, with a secondary code of HLAIAIAA, Genetic & Genomic Rare Disease Therapeutics. Its NAICS code is 541618 and its SIC code is 8742.