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, ISPK
  • Deficiency letter
  • Development plan
  • Project team / drug development team
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigator‘s Brochure (IB)
  • Integrated study report, trial protocol, study outline/synopsis
  • Orphan Drug Designations
  • Scientific Advice (Briefing Book, EMA, US-FDA, BfArM)
  • Meeting with Health Authorities: participation, presentation, Wrap-up
  • OTC-approval
  • Paediatric 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-PIL
  • Scientific product monograph, Product profile
  • Publication
  • Patent (e.g. medical use patent)
  • SWOT Analysis
  • Medical Writing
  • Non-clinical development: consultancy and project management
  • Pharmaceutical development: consultancy and project management
  • Serious Adverse Events (SAEs): evaluation
  • Defense of drugs to Health Authorities
  • Periodic 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.