cote orphan consulting

What cote orphan consulting does

Coté Orphan Consulting is a regulatory affairs advisory firm focused exclusively on orphan drugs and rare disease therapies. Founded in 2012 by Dr. Timothy Coté, the former Director of the FDA's Office of Orphan Products Development, the firm is headquartered in Silver Spring, MD. The company provides specialized consulting services to biotech and pharmaceutical companies developing rare disease treatments, including FDA orphan drug designation applications, breakthrough therapy designation requests, pediatric priority review voucher strategy, and broader regulatory pathway planning. The firm reports having served over 150 biotech and pharmaceutical clients since inception, with a small team of approximately 10-15 regulatory experts, medical officers, and business development professionals.

The firm's core product surface includes the OrphanDB mobile application, which provides access to tracking data for FDA and EMA orphan drug designations, and a clinical research organization (CRO) subsidiary named Coté Orphan Clinical Trials, established in 2014 with a $7 million anchor contract to extend service offerings into clinical trial execution. The firm maintains a strategic alliance with ERA Consulting Group (UK, Germany, Australia) for geographic coverage and maintains presence at industry conferences including BIO, DIA, NORD, and ASGCT. The business model is professional services-based, generating revenue through project fees, milestone contracts, and hourly consulting rates typical of boutique regulatory affairs advisory firms.

Revenue mechanics rely on per-project pricing for FDA designation filings (typically tens of thousands of dollars per application), larger milestone-based contracts for breakthrough therapy and priority review voucher engagements, and CRO contract revenue through the clinical trials subsidiary. The customer base is primarily small-to-mid-cap biotech companies developing rare disease therapeutics, with the firm also targeting venture capital and investment firms evaluating orphan drug deal flow. Geographic expansion efforts include dedicated EU business development leadership and the ERA Consulting Group alliance covering three additional markets.

Name

cote orphan consulting

Legal name

Coté Orphan, LLC

Website

https://coteorphan.com

Company type

Private

Founded year

2012

Operating status

Operating

Short description

Coté Orphan Consulting is a Silver Spring, MD-based regulatory affairs advisory firm founded in 2012 by former FDA Office of Orphan Products Development Director Dr. Timothy Coté, providing orphan drug designation, breakthrough therapy, and CRO services to 150+ biotech and pharmaceutical clients.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA)

akta.pro secondary industry

Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN)

Keywords

• Orphan drug consulting
• Regulatory affairs services
• FDA orphan designation
• Rare disease therapeutics
• Clinical research organization

Headquarters

HQ city

Silver Spring

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Regulatory Affairs Consulting: Professional consulting services including FDA orphan designation applications, breakthrough therapy designations, pediatric priority review vouchers, and regulatory strategic planning. Revenue is generated through project-based consulting engagements with biotech and pharmaceutical companies.
2. Clinical Research Organization (CRO) Services: Clinical trial design services through Coté Orphan Clinical Trials subsidiary. The company signed a $7 million contract establishing this full-service CRO to help organizations navigate clinical trials process through regulatory affairs lens.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Coté Orphan provides expert regulatory affairs consulting to biotech and pharmaceutical companies developing orphan drugs and therapies for rare diseases. Core services include FDA orphan designation applications, breakthrough therapy designations, pediatric priority review vouchers, regulatory strategic planning, FDA and EMA meeting preparation, and full-service clinical trial design and oversight through its subsidiary Coté Orphan Clinical Trials. The firm also maintains OrphanDB, a free mobile application offering searchable access to FDA and EMA orphan drug designation status.

Product overview

Coté Orphan is a regulatory affairs advisory firm providing expert consulting services to help biotech and pharmaceutical companies navigate the orphan drug regulatory landscape. The firm offers a unified service portfolio anchored by OrphanDB, a mobile application that provides single source of truth for FDA and EMA orphan drug designation status. Core services include Orphan Regulatory Affairs (orphan drug designations, FDA meetings, pathways to marketing authorization), Clinical Trials as a full-service CRO, and regulatory strategic planning. The company was founded in 2012 by Dr. Timothy R. Coté, former Director of FDA's Office of Orphan Products Development, and has served over 150 major biotech and pharmaceutical companies.

Differentiator

Problem solved

Functional benefit

Brands

• OrphanDB: Free mobile application providing single source of truth for FDA and EMA orphan drug designation status through contextual search and push notifications.

Products and services

• Orphan Regulatory Affairs Consulting
• Coté Orphan Clinical Trials (CRO Services) Full-service clinical research organization (CRO) services for orphan drug clinical trials, delivered through a wholly-owned subsidiary. Services include clinical trial design, budgeting, investigator selection, site initiation, monitoring, data analysis, report writing, and pharmacovigilance.
• Regulatory Strategic Planning Services Regulatory strategic planning and execution services for companies developing or seeking to develop orphan drugs, including development pathway design and program-level regulatory strategy.
• OrphanDB Mobile Application Free mobile application available on iOS and Android that provides instant access to FDA and EMA orphan drug designation status through granular search by disease, active compound, trade or generic name, and sponsor company. Features configurable push notifications to follow orphan drug status updates.

Quantifiable outcome

• Successfully provided regulatory consulting services to over 150 major biotech and pharmaceutical companies
• +1 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• ERA Consulting GroupflagshipStrategic or Co-development Partner · 23 September 2014Coté Orphan Consulting and ERA Consulting Group established a strategic transatlantic alliance to provide comprehensive services to clients developing products for orphan indications. ERA brings over 27 years of experience in biologics including gene and cell therapy products, CMC and nonclinical expertise, EU orphan medicinal product status, and electronic publishing capabilities for FDA and EU submissions. Together they provide advice at all stages of orphan drug development from concept through BLAs/MAAs. ERA has offices in the UK (2), Germany, Washington DC, and Brisbane, Australia.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• NDA Partners: NDA Partners is a boutique regulatory and development consulting firm that provides regulatory strategy, FDA/EMA interaction support, and drug-development advice to pharma and biotech clients. It is the closest direct peer to Coté Orphan — same business model, similar client base, and overlapping service lines in regulatory affairs.
• Camargo Pharmaceutical Services: Camargo is a regulatory strategy and drug development consulting firm with deep expertise in 505(b)(2), orphan drug, and specialty pharmaceutical pathways. It serves the same biotech and pharma client base seeking specialized regulatory guidance and mirrors Coté Orphan's boutique advisory model.
• PharmaLex: PharmaLex is a regulatory affairs and development consulting provider offering services across FDA, EMA, and global health authorities, including specialized support for orphan drug designations. It is comparable as a mid-sized regulatory-focused consulting firm serving the same biotech/pharma market.
• Voisin Consulting Life Sciences: Voisin Consulting Life Sciences is a regulatory and clinical strategy consulting firm supporting biotech and pharma across FDA and EMA submissions. It overlaps with Coté Orphan's regulatory strategy and orphan-drug pathway advisory offerings for similar client segments.

Broad incumbents

• Parexel International: Parexel is one of the largest global CROs offering regulatory affairs, clinical trials, and commercialization services to pharma/biotech, including dedicated rare-disease and orphan-drug capabilities. It competes with Coté Orphan at the upper end where clients seek bundled CRO and regulatory services.
• IQVIA: IQVIA is a leading global CRO and life-sciences services platform providing regulatory consulting, clinical operations, and post-approval services across all major therapeutic areas. It is a broad incumbent that competes for the same biotech/pharma regulatory budgets as Coté Orphan but as part of a much wider service portfolio.
• ICON plc: ICON is a major global CRO offering regulatory consulting, clinical trial design, and full-service development support to pharma/biotech sponsors. Comparable as a broad incumbent competing for the same regulatory and clinical development engagements, though without Coté Orphan's orphan-drug specialization.
• Charles River Laboratories: Charles River Laboratories is a large CRO and life-sciences services provider with regulatory consulting and clinical development capabilities serving biotech and pharma. It is a broad incumbent competitor for the same regulatory and clinical trial engagements as Coté Orphan, but across a much broader portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cote-orphan-consulting-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about cote orphan consulting