Regulatory Affairs (4)

Medical device 510(k) submission strategy Alacrita’s client had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to...

Alacrita Consulting's founders worked together for over 10 years at Onyvax, a London-based cancer immunotherapy company backed by SR One. We have conducted a number of consulting projects in the...

Background Alacrita`s client was nearing the completion of a pivotal Phase III with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum...