Orphan Drug Consulting

What Orphan Drug Consulting does

Orphan Drug Consulting Ltd is a privately held pharmaceutical consulting firm founded in 2017 in Dublin, Ireland, by Evelyn Kelly. The firm provides end-to-end management and technical support to pharmaceutical and biopharmaceutical companies launching new products globally, with a specialized focus on orphan drugs and rare-disease therapies. Its service portfolio comprises five core lines — Executive Support (strategic review, entity structuring, launch readiness, global trade compliance, managed access programs), Quality Assurance (QMS, license acquisition, QP/RP/FvP services, audits), Supply Chain (S&OP, clinical and commercial supply, packaging, serialization), Cross Functional Solutions (transport and vendor management), and Customs/Import VAT Support — delivered through four engagement models: Advisory, Consultancy, Implementation, and Managed Services.

The firm operates from four offices — Dublin (headquarters), London, Boston/Cambridge, and Melbourne — staffed by approximately 25-26 employees, the majority of whom are senior practitioners previously employed at rare-disease and specialty pharma companies such as NPS Pharma, Shire, Amicus Therapeutics, Jazz Pharmaceuticals, Alexion, Genzyme, Novartis, and Merck. The team includes specialized Qualified Person (QP), Responsible Person (RP), and Fachperson (FvP) capacity required for EU/UK/Swiss batch certification and release.

Go-to-market is sales-led and event-driven, with active participation in BIO, CPHI, the World Orphan Drug Congress, Swiss Biotech Day, and AusBiotech, supplemented by proprietary workshops in Zurich, Boston, and Melbourne and a content-marketing presence through the firm's Knowledge Hub. Revenue is generated through tailored consulting engagements with quote-based pricing across advisory, implementation, and recurring managed-services contracts; the firm cites 70+ pharma/biopharma clients and 100+ successful country launches across Europe, North America, LATAM, and APAC. The company is founder-led with no disclosed external institutional investment and no subsidiaries.

Name

Orphan Drug Consulting

Legal name

Orphan Drug Consulting Ltd

Website

https://orphandrugconsulting.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Orphan Drug Consulting is a Dublin-headquartered boutique pharma consultancy that provides end-to-end regulatory, quality assurance, supply chain, and market access support to pharmaceutical and biopharmaceutical companies launching orphan drugs globally.

Ownership category

akta.pro rank

Headquarters

HQ city

Dublin , Dublin

HQ country

Ireland

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Advisory Consulting: Strategic consulting services to determine strategy and execution readiness for client requirements
2. Implementation Services: Implementation of launch plans, license acquisition, entity set up and vendor management
3. Managed Services: Continued support services such as customs support, provision of QP/RP/FvP and batch release

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Orphan Drug Consulting provides end-to-end management and technical consulting services to pharmaceutical and biopharmaceutical companies launching new products globally, with a specialized focus on orphan drugs and rare disease therapies. The firm's service portfolio spans five functional areas — Executive Support, Quality Assurance, Supply Chain, Cross Functional Solutions, and Customs/Import VAT Support — delivered via four engagement models (Advisory, Consultancy, Implementation, and Managed Services) tailored to client stage from preclinical through commercial.

Product overview

Orphan Drug Consulting is a consulting services firm, not a software product company. They provide end-to-end management and technical support to pharmaceutical and biopharmaceutical companies launching new products globally. Their service portfolio consists of five core consulting service lines: Executive Support (strategic review, entity structuring, launch readiness, global trade compliance, managed access programs), Quality Assurance (QMS, license acquisition, QP/RP services, audits), Supply Chain (inventory, clinical/commercial supply, packaging, serialisation), Cross Functional Solutions (transport, vendor management), and Customs/Import VAT Support. These services are delivered through four engagement models: Advisory, Consultancy, Implementation, and Managed Services. The firm also provides educational content through their Knowledge Hub covering regulatory topics like EMA procedures, Brexit impacts, COVID-19 guidance, and ATMPs.

Differentiator

Problem solved

Functional benefit

Products and services

• Executive Support Strategic advisory and readiness services for pharma/biopharma executives including strategic review, entity structuring and organisation design, launch readiness review, strategic guidance on global trade compliance, and managed access program support. Targeted at pharmaceutical and biopharmaceutical company leadership preparing for or executing product launches globally.
• Quality Assurance Comprehensive QA services for pharmaceutical and biopharmaceutical companies including QMS gap assessment and implementation, wholesale distribution authorisation (WDA) license acquisition, Swiss pharmaceutical establishment license acquisition, MAH point of contact, Responsible Person (RP) services, Qualified Person (QP) services for commercial products and IMP, audit and inspection services, and quality and technical agreements. Targeted at pharma/biopharma companies needing quality system and licensed-person coverage in Europe and other regulated markets.
• Supply Chain Supply chain management services for pharma/biopharma companies covering inventory and forecasting including Sales & Operations Planning (S&OP), clinical supply chain, commercial supply chain, artwork and packaging optimisation, and serialisation. Targeted at pharmaceutical and biopharmaceutical companies needing supply chain design, planning, and operational support for orphan drug and rare disease portfolios.
• Cross Functional Solutions Cross-functional consulting support covering transport management, transport validation, vendor processes, vendor selection and onboarding, and vendor management. Targeted at pharmaceutical and biopharmaceutical companies needing coordinated cross-functional execution support during launches and ongoing operations.
• Customs / Import VAT Support Customs and import VAT services for pharmaceutical and biopharmaceutical companies including valuation determination, EORI registration support, and import VAT registration and management. Targeted at pharma/biopharma companies entering or operating in European markets that require customs and tax compliance support.

Quantifiable outcome

• Supported over 70+ Pharma and Biopharma Companies with successful launches
• +1 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Three partnerships are on record, tiered minor.

• AlmacminorGTM or Marketing Partner · 21 June 2022Frances Pierce, Head of Supply Chain at Orphan Drug Consulting, presented at Almac's Product Launch Success Workshop in Dublin on 'Trade, custom, and import/export considerations'.
• Perigord Life Science SolutionsminorGTM or Marketing Partner · 27 January 2021Co-hosted a webinar on 'Launching an RX Product in the EU' with Lenny Figorski, Head of Consultancy at Perigord Life Science Solutions. The partnership involved shared expertise delivery on EU product launch, packaging, and artwork considerations.
• ArriellominorGTM or Marketing PartnerOrphan Drug Consulting supported Arriello as a guest speaker at an upcoming workshop in MassBio Hub, Boston titled 'European Readiness: Building Confidence from Development to Entry'. This represents a marketing/knowledge-sharing partnership in the Boston biopharma hub.

Scale indicators5 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• ICON plc: Global CRO and consulting firm serving pharma, biotech, and medical device companies with regulatory and commercialization support. Broad incumbent that intersects with ODC's regulatory and launch services at the upper end of the market.
• IQVIA: Largest life sciences services firm with deep regulatory, quality, and commercialization consulting practices serving global pharma. Competes with ODC on enterprise regulatory engagements but operates at vastly greater scale and breadth.
• Parexel International: One of the largest global CROs offering regulatory consulting, clinical development, and commercialization services to pharma/biotech. A broader incumbent that overlaps with ODC in regulatory affairs and launch support but at a much larger scale.
• Charles River Laboratories: Large CRO/CDMO offering regulatory consulting, manufacturing, and quality services across the drug development lifecycle. Broad incumbent that overlaps with ODC in regulatory and quality support for orphan drug clients.

Direct peers

• Arriello: Regulatory and compliance consultancy for pharma and biotech, including services around EU market entry, MAH support, and quality systems. Comparable specialty in regulatory/QA and EU market access; co-markets with ODC.
• ProPharma Group: Pharma/biotech consulting firm providing regulatory affairs, quality compliance, clinical research, and pharmacovigilance services to drug developers. Directly comparable in being a specialized life sciences consultancy serving similar pharma and rare disease clients.
• PharmaLex: Specialized pharmaceutical regulatory affairs, quality, and consulting services firm focused on helping drug developers navigate complex approvals, including orphan drug pathways. Closely comparable niche and service mix to ODC, though larger and now part of Cencora/World Courier.
• Diamond Pharma Services: Specialty pharma services firm offering regulatory affairs, pharmacovigilance, medical affairs, and quality support to drug developers. Comparable in serving orphan drug and rare disease sponsors with integrated consulting services.
• Latham BioPharm Group (Latham): Boutique consulting firm providing regulatory strategy, CMC, and quality/compliance services to small and mid-sized pharma/biotech, with strength in rare disease. Closely comparable niche focus and delivery model to ODC.

Others

• Perigord Life Science Solutions: Provider of packaging, artwork, and labeling services for pharma launches, including serialization and EU launch support. Adjacent ecosystem partner that co-hosts webinars with ODC on EU product launches.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/orphan-drug-consulting

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

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 Orphan Drug Consulting