Project Closed

eCTD Templates, Publishing and Medical Writing- 3 US INDs

Small Seattle based sponsor working to bring 3 compounds to market- oncology, Covid19 vaccine and schistosoma disease.  Content is in various stages of completion- mostly drug substance.  Need medical writing support (have synopsis but not protocol) as well as publishing in the eCTD format.  We have done INDs before but always in paper.  Have been told by agency that we need eCTD templates, or at a minimum to have each IND in correct eCTD format.   Hoping to submit Covid19 IND in q3 2020, oncology IND in Q1 2021.