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 ...

Senior Manager of Global Regulatory Affairs for Wyeth discusses the implementation of eCTD and selecting the proper vendor. After a roundtable discussion on eCTD implementation that brought together ...

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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 ...

NEW YORK, Feb. 5 Intrasphere Technologies, a leadingconsulting firm that provides business-focused services and solutions to lifesciences organizations, announced today that the company's ...