Topic: Common Technical Document (CTD)

Process optimization, effective management, and organisation strategies are all essential components when preparing CTD submission dossiers for drug approval. 

In this episode, Douglas, Senior Partner at Trilogy Writing & Consulting, and Johan Telen, President at Improvement at Work, discuss how implementing well-planned, focused, and robust processes can actively de-risk the critical path and contribute to reducing the time needed for dossier preparation.

In this episode, Julia and Douglas, Senior Partners at Trilogy Writing & Consulting, discuss how preparing written responses to questions received from regulatory agencies during the review of application dossiers can be decisive to the outcome of the review, and how medical writers can make a substantial contribution to this process.

In this episode, Julia Forjanic Klapproth, Senior Partner, and Maurice Löwens, Medical Writing Manager at Trilogy Writing & Consulting, discuss how experienced medical writers can streamline the planning and writing process of oncology dossiers, helping the team navigate a minefield of potential problems and advising the team on how to present the information with clarity that will direct agency reviewers to what they are looking for and aid the approval process.