Services to Ease FDA Regulatory Compliance

 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, … Continue reading eCTD Requirements and cost effective solutions →