ISI eSubSource services cover all aspects of fulfilling electronic submission requirements including: global submissions, full CDER and CBER electronic submissions, cumulative marketing applications, and now the capability to provide eCTD submission services. ISI eSubSource services encompass, but are not limited to, scanning, electronic submission assembly and paper publishing.

Utilizng our own tried and tested software, we deliver unmatched, quality services to the industry. With ISI guiding you every step of the way, rest assured your submission will be in compliance and on time, ready to deliver to any agency with confidence.

eSubSource specializes in submission delivery such as:

• eCTDs, eNDAs, eBLAs, MAAs, eINDs
• Paper CTDs
• US, EU, Japan, worldwide submissions
• Transition from paper to electronic submissions
• Transition to eCTD
• Cumulative Marketing Applications
• Case Report Form (CRF) and Case Report Tabulations (CRT) processing

If you are looking to outsource electronic or paper submission services, from start to finish, ISI can deliver.