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.
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.
North American Office
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.