CR Pharma Consult is a one-person consultancy company founded in March 2016 by Carsten Roepstorff and offering consultancy services within medical writing, clinical pharmacology and trial management. Carsten holds a Ph.D. in Human Physiology (2004) and a post-graduate diploma in Pharmaceutical Medicine (2013), and has 12 years of combined experience within clinical pharmacology, medical writing and trial management. Thus, having a broad understanding of the end-to-end clinical development process. Carsten has substantial experience in authoring clinical study protocols, investigator’s brochures, clinical study reports, clinical summaries, abstracts, posters and manuscripts. Carsten has been medical writer on various clinical studies, phase 1 to phase 3. In relation to MAAs/INDs, he has prepared clinical documents for submission and has been instrumental in the Q&A process with health authorities. Moreover, his hands on experience in designing, planning, executing and interpreting clinical pharmacology studies has given highly relevant clinical operational insight. Carsten has previously been lead clinical pharmacology scientist on various projects within diabetes, and has been involved in health authority interaction during development, submission and subsequent inspections from and dialogue with health authorities. This has given solid experience with project management as well as profound regulatory understanding.