our area of work comprises all aspects of

Medical Writing

• Clinical sections for regulatory approvals of clinical trials (CTX, IND, Hinterlegung)
• Study protocols from outlines
• Investigator Brochures
• Reports to ICH standards
• Clinical summaries for common technical documents
• SmPCs (summary of product characteristics)
• Routine safety updates
• Scientific publications (original articles and reviews), abstracts, and posters in German or English
• User information (in German or English): Training manuals, prescriber brochures (product and disease areas), patient brochures
• Congress reports
• Translations, German/English/German, of all the types of documents