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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 information.

Medical Writing

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
Publications
Patents (incl. Medical Use patents)
SWOT analyses
Benefit/risk profiles.

Pharmacovigilance
Serious adverse events (SAE) evaluation
Defense of drugs vis-a-vis health authorities
Periodic Safety Update Reports (PSUR).

Troubleshooting
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.