Phortas GmbH services

Our Medical Writers can help you develop all documents needed to be included into the Marketing Authorization Dossier under the Common Technical Document (CTD) format.

Our experienced Consultants will help you prepare all necessary documentation, manage all preparations and accompany your team to any Scientific Advice or Pre-submission meeting with any Regulatory Authority. We have prepared and attended a number of successful meetings with Authorities worldwide.

Our Medical Writers can help you develop all documents needed to support your product in a development phase: Investigators Brochure (IB), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Report (DSUR), Clinical Study Protocols and Reports, Pediatric Plans, Briefing Documents for any Authority meeting, etc.