The staff of DR. RIETHMÜLLER M/R/S is highly experienced in covering all steps of the development
process of medicines and medical devices as well as in postmarketing activities. A catalogue of
services is presented below. Please feel free to contact us should you require any additional
Common Technical Document (CTD):
Clinical and Preclinical Overviews and Summaries
Integrated Summaries (FDA, Canada): ISE, ISS, ISCP, ISPK
Investigators' Brochure (IB)
Integrated study reports, study protocols, study outlines
Patient information leaflets, SPC, US-PIL
Product Profiles, Scientific Drug Brochures
Patents (incl. Medical Use patents)
Serious adverse events (SAE) evaluation
Defense of drugs vis-a-vis health authorities
Periodic Safety Update Reports (PSUR).
e.g. support in finishing studies on time
Preparation of files for health authorities.
Organization of symposia/workshops
e.g. on national and international congresses.