Authoring of IND Module 3, US Client

Category: Regulatory Affairs Consulting
US based biopharmaceutical company engaged Cilatus Regulatory to author the Phase 1 IND Module 3 for a recombinant protein. Working to tight timelines, Cilatus took source documents and authored the IND Module 3. Cilatus integrated with the company Technical Operations team to author sections as data and information became available. Cilatus led and managed multiple review cycles of the Module 3 documents. Cilatus project managed delivery of the sections to the client in line with the corporate timeline for IND submission. All Module 3 sections were delivered fully formatted for submission. The IND was successfully submitted to FDA with no significant CMC questions or issues raised. Cilatus continues to provide Regulatory support to this client.