What is eCTD publishing?

eCTD publishing refers to the process of preparing and compiling regulatory submission documents in the Electronic Common Technical Document (eCTD) format, which is required by health authorities like the FDA and EMA. This process involves organizing, formatting, hyperlinking, bookmarking, and validating documents to meet strict technical standards for electronic submissions. eCTD publishers use specialized software to ensure that all documents are compliant, navigable, and accepted by regulatory agencies. The goal is to facilitate the review and approval of pharmaceuticals and biologics by providing a standardized electronic format for submissions.