120-Day safety update (FDA)
Neurology program for a medium sized biopharmaceutical company
Following the success of a Biological License Application, a project for which BioVentures Consulting Limited was awarded repeat contracts over a continuous period of 4 years since clinical Phase II, the services of BioVentures Consulting Limited were continued to oversee the submission of the 120-Day safety update application required by the US FDA. The brief involved leading cross-functional teams of clinical, statistical, medical writing and regulatory affairs experts in order to co-ordinating responses to FDA questions during the BLA assessment phase, and successfully submitting the 120-Day application on time. The result was a successful submission and ultimate approval of the BLA.