Regulatory Open Forum

 View Only
  • 1.  eSubmission Express

    Posted 01-Sep-2020 22:19
    Edited by Tina O'Brien 01-Sep-2020 23:18
    I need to start compiling my company's first NeeS for an EU submission and don't have the bandwidth or patience to manage it manually via Windows Explorer.  I also have zero budget for a fancy RIM/publishing application.  I stumbled upon eSubmission Express that will allow me to purchase only what I need now and work in the cloud, thus don't need to involve IT resources. 

    Before I move forward, wondering if anyone has used this vendor and would care to share feedback?  Also, any other suggestions for low cost NeeS/eCTD systems?

    Thanks!

    Tina

    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
    ------------------------------


  • 2.  RE: eSubmission Express

    This message was posted by a user wishing to remain anonymous
    Posted 02-Sep-2020 11:01
    This message was posted by a user wishing to remain anonymous

    Hi Tina,

    One option is Lorenz (website: lorenz.cc).  They offer a single-user, pay-as-you-go, cloud-based option called docuBridge ONE.


  • 3.  RE: eSubmission Express

    Posted 03-Sep-2020 05:47
    Hi,
    I'm Prathap D.V from Accenture Solutions Pvt Ltd. We also do provide services in EU submissions. We have presence at US, UK, Pl and India. If you need further details we can discuss further. I can guide for Point of contact on further clarification. 
    Regards, 
    Prathap

    ------------------------------
    Prathap Vedhavyasamurthy
    Regulatory Opertions - Business Process Delivery Team Leader
    Bengaluru
    India
    ------------------------------