Partum was approached by a client to lead and co-ordinate Day 120 responses to close of the MAA procedure by a small pharmaceutical company based in the EU and US. Partum reviewed the submitted MAA dossier and created a list of potential questions from the EMA in conjunction with the Subject Matter Expert Input and started working on responses with the Day 80 Assessment Report receipt. Partum supported the client by fore-front planning and initiation on analysis to support responses at the appropriate time to meet the responses deadline and achieving the best planned timeline scenario for the MAA.