We are a team of highly-qualified scientists who offer professional medical writing services. As dedicated writers with substantial publication records (well over 100 publications in peer-reviewed journals) and knowledge of a wide range of therapeutic areas, we specialize in writing and compiling documents for submission to pharmaceutical regulatory authorities. For example, we produce non-clinical and clinical overviews and summaries for marketing authorization applications, briefing books, response documents, clinical study reports, and contribute to core value dossiers for market access. We add value by virtue of our strong academic backgrounds, pharmaceutical industry experience and deep grasp of medical sciences.
Through memberships and contact with professional bodies (EMWA, TOPRA, ECPM), we maintain an up-to-date knowledge of regulatory issues. We are native English-speakers and fluent in German, French and Italian.
Our academic and industry experience spans a broad range of medical and scientific areas: