1. ABOUT GARDP FOUNDATION

The Global Antibiotic Research & Development Partnership (GARDP Foundation) is a not-for-profit global health organization registered in Geneva, Switzerland. GARDP’s mission is to accelerate the development and access of treatments for drug-resistant bacterial infections. It does so by forging public-private partnerships all over the world to develop and expand access to treatments for serious bacterial infections and sepsis in adults, children and newborns, as well as sexually transmitted infections (STIs).

GARDP Foundation responds to the crisis in antimicrobial resistance. In 2015, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance. The following year, to deliver on this plan, WHO and the Drugs for Neglected Diseases initiative created GARDP. In 2018, the GARDP Foundation was legally established as an independent entity.

Since then, GARDP Foundation has developed a portfolio of antibiotic treatments that targets WHO priority pathogens, priority diseases and key populations/regions that are especially affected by drug resistance. It is also pioneering new access initiatives with innovator, manufacturing and distribution partners.

As of 2024, the GARDP team consists of about 100 people who collectively share extensive cross-sector R&D and access experience. They work with the key public and private sector stakeholders and partners, such as the research and development community, donors, industry and implementing countries.

2. PROJECT BACKGROUND & PURPOSE OF THE RFP

Background to project
The new drug application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) and awaits approval. To enable commercialization in the European Union, the NDA dossier should be adapted to meet EMA regulatory, technical, and formatting requirements.

Purpose of RFP
GARDP seeks a service provider to support the registration of a GARDP drug with the European Medicines Agency (EMA). The service provider will adapt and leverage the existing U.S. New Drug Application (NDA) dossier for submission under the European Union (EU) Marketing Authorization Application (MAA) process via the centralised procedure.

If you are interested to receive the complete documentation, please review, complete and sign that attached confidential framework and send it to: RFP_Procurement@gardp.org.

Due/closing date: January 15th 2026