The efficient and accurate production of eCTD's dictates an understanding of the International Conference on Harmonization (ICH) and Regional Regulatory agency's requirements.  Regulatory eSubmissions, LLC can perform an assessment of your current document production and identify areas requiring adjustment.  The establishment of organizational standards for the production of submission documents is a key to the efficient production of eCTD's.  At the conclusion of this process you will have an understanding of the documents which comprise the submission, the meaning and best use of document granularity for your organization and how these will contribute to cost effective eCTD production.