Welcome to
Orphan Drug Consulting

We are a dedicated team of experienced professionals. We love what we do, and are passionate about our clients’ success. With over 150 years executive experience in Supply Chain, Quality Assurance, Compliance, Customs/VAT, Vendor Management, Entity/Corporate Support, and Product Launch, our team is your team.

Welcome to
Orphan Drug Consulting

We are a dedicated team of experienced professionals. We love what we do, and are passionate about our clients’ success. With over 150 years executive experience in Supply Chain, Quality Assurance, Compliance, Customs/VAT, Vendor Management, Entity/Corporate Support, and Product Launch, our team is your team.

Strategy & Entity Management​

Supply Chain

QA & Compliance

Vendor Management

Product Launch

Our Approach

We are renowned for listening to your goals, asking the right questions and identifying gaps that you might not have considered to develop an operational plan for you and your team. We take your requirements and translate them across extensive legislative frameworks into practical operational goals to achieve successful product launch.  

Through our initial free consultation service, we will provide you with a service framework to support you to bring your drug to market, on time, every time.

End-to-end Consulting

Orphan Drug Consulting is your expert through the product launch lifecycle. We provide you with end-to-end support, advice, coordination and direction to ensure the successful delivery of your product to new markets in the EU, the US and around the world. With a highly qualified, experienced and dedicated team, we specialize in providing drug launch lifecycle services to the biopharma and pharmaceutical industries. 

 

Testimonials

ABC
Sophie Grant
DEF
James Stinger
GHI
Amy Winter

European Office

North American Office

Orphan Drugs and Rare Diseases

> 0
Estimated Distinct Rare Diseases in the World​
> 0 Million
People Living with a Rare Disease
~ 0 %
Rare Diseases Affect Children
> 0
Orphan Drugs Authorized in the EU

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.