Partum was approached to lead, co-ordinate and provide oversight for one Phase II (non-registrational) and Phase 3 (registrational trial) clinical trial strategy and submissions across the globe by a medium-sized biotechnology company. Partum led the submissions in the US (IND), 8 countries in the EU (CTA) and 2 RoW (CTA/CTN) countries. Partum supported and provided solution-based strategy when encountered with numerous local regulatory challenges in the EU and RoW. This experience was steep learning curve for both client and Partum. We have a continued relationship with the client to support their other upcoming assets.