On behalf of a European pharmaceutical company, one of Alacrita’s professionals acted as medical director for the registration of a new agent in a neuroendocrine indication in territories outside the US. Alacrita was brought in by the client five months before the planned MAA submission date after the internal medical director and other key team members unexpectedly left the company and could not be replaced internally.
During the five-month period, the team finalised the study reports, wrote the overview and the SmPC for the submission as well as preparing an ODD application (which was granted). The team received numerous questions from the rapporteur and co rapporteur and the same team worked on the responses to questions, including new statistical analyses of the clinical data. The Alacrita medic represented the company in regulatory agency meetings and the product was successfully steered through regulatory approval. Following this, submissions were prepared for other non-US territories and the dossier was transitioned to the client’s commercial team.
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