UNDERSTANDING AND IMPLEMENTING DOSSIER REQUIREMENTS
European and national guidelines regulate the substantive requirements for your medicinal product dossier. The structure for drawing up the dossier is provided by the Common Technical Document.
We would be glad to prepare your medicinal product dossier so that it meets all of these requirements.
- GAP analysis of existing documents/dossiers
- Preparation of documentation in accordance with administrative and regional requirements (Module 1) for submission in the EU
- Preparation of clinical, preclinical and/or quality documents, overviews and statements for the medicinal product dossier
- Preparation and/or assembly of the dossier as an electronic or paper CTD (Modules 1-5)