Services and Consulting
Clinical, non-clinical and pharmaceutical projects
A catalogue of services is presented below.
The staff of DR. RIETHMÜLLER M/R/S is highly experienced in covering all steps of the development process of medicines, medical devices and diagnostics as well as in post‑marketing activities.
Please feel free to contact us should you require any additional information.Common Technical Document (CTD)
Clinical und non-clinical Overviews und Summaries Integrated Summaries (FDA, Canada): ISE, ISS, ISCP, ISPKDeficiency letterDevelopment planProject team / drug development teamInvestigational Medicinal Product Dossier (IMPD)Investigator‘s Brochure (IB)Integrated study report, trial protocol, study outline/synopsisOrphan Drug DesignationsScientific Advice (Briefing Book, EMA, US-FDA, BfArM)Meeting with Health Authorities: participation, presentation, Wrap-upOTC-approvalPaediatric Investigation Plans (PIP, EU)Initial Pediatric Study Plans (iPSP; US-FDA)Data Monitoring Committee (DMC)Data and Safety Monitoring Board (DSMB)Patient information, SmPC, US-PILScientific product monograph, Product profilePublicationPatent (e.g. medical use patent)SWOT AnalysisMedical WritingNon-clinical development: consultancy and project managementPharmaceutical development: consultancy and project management Serious Adverse Events (SAEs): evaluationDefense of drugs to Health AuthoritiesPeriodic Safety Update Reports (PSUR)For the successful performance of clinical trials, we cooperate with highly qualified experts, investigators, Health Authorities, CROs (monitoring of clinical trials, data management), and biostatisticians.