For regulatory dossiers document format truly matters. Doing things right from the beginning is definitively the shortest and most cost efficient way to submission.
At IWA Consulting we have long term and hands on experience in handling eCTD and we know what it takes preparing documents and templates that are eCTD compatible.
The technical validation of an eCTD requires that the documents are converted to navigational PDF documents with the required settings for table of contents, bookmarks, hyperlinks etc. The IWA Consulting Team can help you converting Word documents to PDF using our Adlib PDF rendering software and optimizing old PDF documents ensuring that all PDF requirements are met.
We have expertise in establishing efficient workflows and review cycles and to establish the routines for finalizing and sign off for quality controlled documents.
Whether you are facing dossier preparation for initial eCTD submission or life cycle management, we have the expertise to advise and assist you before, during, and after submission.
For more information about document management, please contact Regulatory Operations Team