Five-module architecture organizes massive amounts of information included in a marketing submission. Is your organization planning for the transition to electronic submissions using the eCTD ...

Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...

Opened on June 26, 2019 and will close to new input on August 26, 2019. This is a technical document that provides instruction on how to implement the International Council for Harmonisation (ICH) ...

The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates. This article covers the submission requirements ...