Early access programs
EAPs, Name Patient, and Compassionate use programs deserve the attention of highly qualified professionals who appreciate the significance of these initiatives and understand the urgency these programs require.
Euromed Pharma is set up to support the industry and the single individuals to ensure patient access to medicines from their very early stages of clinical development, through Phase I, II, and III, and if the product was just approved in a country but not yet in another.
Name Patients Programs
Early access programs, (EAPs) are being used by an increasing number of pharma companies to ensure access to therapies also for patients from serious life-threatening or rare diseases that cannot take part in a clinical trial or have no treatment options available. Patients who do not qualify for clinical trials nor the EAP program can reserve the right to use patient access.
Pre-Approval Access Managed Access
These EAPs are also implemented when the drug is approved in one country but not in another country where it is needed and requested by terminally ill patients. Given the fast pace with which some treatments for life-threatening diseases are advancing, the industry is counting more than ever on organizations who can support them in making sure that through their EAPs they can offer ethical, compliant, and controlled mechanisms to provide access to investigational drugs outside of their clinical trials and or countries where the product may not be registered yet.
Orphan Drugs Services
EAPs are also implemented for rare and orphan diseases. For pharmaceutical companies developing orphan drugs, EAP is often the preferred option, instead of seeking a full-scale regulatory approval. Differences in national regulations about the implementation of EAPs pose a significant challenge to pharma companies
Our objective is to ensure that you, as the Sponsor, have the time to focus on the advancement of your drug product. while will take on not just the management and distribution of these programs, but all the various activities related to it.