eCTD Requirements and cost effective solutions
Electronic Common Technical Document -eCTD eCTD is a harmonized regulatory filing format widely accepted by several countries. ICH adopted countries have common modules 2,3,4, and 5 and customized administrative module 1 according to country-specific requirements. Contents of e-CTD ICH recommended CTD folder structure XML backbone containing metadata such as document id, document version, hyperlinks, file … Continue reading eCTD Requirements and cost effective solutions
