Orphan Drug Consulting

Who we are

We are a team of industry-leading subject matter experts (SME's) and professionals who provide consulting services to innovative pharmaceutical and biotech companies, meeting their needs and launching products to global markets.

Meet The Team

What we do

Combining industry-proven expertise and a clear cross-functional approach, the Orphan Drug Consulting team lead companies through their product launch strategy development, implementation and maintenance post-launch across all global markets, driving functional excellence end-to-end, whilst providing tailored and specific services to meet your immediate company needs.

View Full Service Range

Product Focus Areas

While Orphan Drugs are the cornerstone of the Orphan Drug Consulting business, the team also supports clients across multiple different product types and formulations – from vaccines right through to specialty/high-volume products and anti-microbials, ensuring that companies representing underserved patient populations can bring their medicines to the market.

Rare Disease & Orphan Drugs


Advanced & Novel Therapies

Speciality & High Volume Products


Estimated Distinct Rare Diseases in the World​


People Living with a Rare Disease


Rare Diseases Affect Children


Orphan Drugs Authorized in the EU

In Numbers

Orphan Drugs and Rare Diseases

Orphan Drugs are a classification of medicines used to treat rare and ultra-rare diseases. The exact definition of an Orphan Drug can very according to the relevant authority, however in Europe the European Medicines Agency (EMA) set out criteria that must be met to qualify as an Orphan Drug including:

  • it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;

  • the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development;

  • no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorised, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

Our Company

Relationships Built on Trust

Orphan Drug Consulting offers end-to-end management support to pharmaceutical and biopharmaceutical companies launching in the EU, US and across the world.

We trust in each other and our clients trust in us.

We live a “do it right” culture, first time every time.

We treat our clients, our team and our stakeholders with dignity and mutual respect at all times.

Our cohesive team are leading experts in their fields. We invest in their continued development and knowledge transfer to our clients.

We are driven to achieve our clients’ milestones. We do not shy away from making decisions, setting out recommendations and detailing realistic targets.

We listen, we do not hard sell, and we work to your timetable and objectives.

We deliver on our promises and are committed to our clients.

We always meet our clients’ needs.

We provide outstanding value to our clients throughout the launch lifecycle.