EU Regulatory Lead, US Client

Category: Regulatory Affairs Consulting
Cilatus Regulatory was selected by a US biopharmaceutical company to provide strategic and operational EU regulatory leadership to support the commercial launch and lifecycle management of two orphan drugs. Cilatus co-ordinated and managed regulatory activities, submissions and information requests with EU national affiliate offices. Cilatus managed regulatory aspects of artwork and labelling including the introduction of a new artwork management system and authoring SOPs for the artwork process. Cilatus worked with client QA team to manage Marketing Authorisation Holder responsibilities. Cilatus continues to play a key role in providing EU Regulatory leadership for this client.