eCTD Office – Local Support Partner

eCTD Office is an off-the-shelf suite of integrated eCTD / NeeS / VNeeS software products for the creation, validation, publishing, viewing and manipulation of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities.

Take a look at eCTD Office, even if you already have an eCTD/NeeS/VNeeS software solution, and save on time/money with your next e-submission!

As a local partner, we are able to offer you customer service in the form of:

  • Full technical support.
  • User training on an individual or group basis.

Using eCTD Office you can easily:

  • Compile. Prepare you submission documents and fill in the provided regional-aware approved template. Add documents manually or import/merge an existing eCTD/NeeS.
  • Manipulate. Behind the scenes: easily split and merge your PDF documents, convert MS Word DOC to PDF, define document Titles, attributes, granularity, envelope values, …
  • Validate. Built in validation supporting regional rules ensures no invalid submissions can be generated.
  • Publish. Fire-and-forget. No need to know anything about eCTD XMLs and other IT-related eCTD/NeeS aspects. NeeS TOC files auto-generated and optimized.
  • View. Understand how Authorities see your electronic submission. Reduce review times, increase response times to Agency requests, and ensure faster approvals for your products.
    eCTD Viewer, part of eCTD Office, is a free, also available as a stand-alone, easy to use Windows desktop software application for (re-)viewing and understanding the granularity and the lifecycle of electronic submissions prepared in the eCTD, NeeS, VNeeS and other electronic dossier formats.
  • Manage Lifecylce. As easy as breathing. Understand and manage your eCTD products lifecycle as simple as “assign-operation-target”.

eCTD Office is used by hundreds of small, private, medium sized to tier-one pharma companies and pharmaceutical consultants on all continents for more than 10 years!

Contact us for an offer and a free demo of eCTD Office.