Regulatory support for the development of BTZ-043 through to marketing authorisation

Summary

LMU Klinikum is procuring regulatory, scientific and strategic consulting and support for the development of BTZ-043, a potential antibiotic for tuberculosis, through to marketing authorisation. The services cover development strategy and data-gap reviews; preparation, review, updating and submission of regulatory dossiers; paediatric development plans; interactions with authorities; and support for applications to the EMA and/or FDA, with further support concerning China’s NMPA and ongoing regulatory activities as needed. The work is organised into seven packages and other services, ordered as required under a framework agreement with an estimated value of EUR 1.5 million net and a maximum value of EUR 1.8 million net; there is no obligation to order every service.