Our in-house experts have a proven track record with coordination, compilation, publishing and submission of initial eCTDs as well as supporting the eCTD lifecycle management. 

Our document specialists are experienced in preparation of eCTD compliant documents to meet current FDA submission requirements. The eCTDs published by B&H are highly reviewer friendly; we incorporate effective hyperlinks rather than excessive hyperlinks. 

B&H maintains an account on FDA’s electronic submission gateway (ESG) to provide our clients with worry-free delivery of their electronic submissions to FDA.