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Consult GmbH & Co. KG

 
Experts on
Good Clinical Practice
since 1993
 
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RMC's Services:


Medical-scientific support   —   Drug Safety / Regulatory, services

  • Planning and organisation of medical scientific symposia
  • Close and personal contact to your opinion leaders
  • Clinical research Phase II - IV
  • Preparation and up-dating of training manuals for investigators, study nurses and monitors
  • Clinical protocol audit
  • Monitoring
  • Planning, management and evaluation of Post Marketing Surveillance (PMS/NIS)
  • Writing of and care for your SOPs
  • Extensive experience in dermatology, gastroenterology, pneumology




Drug Safety   —   Medical-scientific support (top)

  • Collecting, evaluation and reporting of adverse drug reactions and potential drug risks as external Pharmacovigilance officer according to German Drug Law § 63a for your company
  • 24-hours telephone service, e.g. in FDA studies can be offered
  • Writing and up-dating of Periodic Safety Up-date Reports (PSURs)
  • Literature search for signal and risk detection




Regulatory, services   —   Medical-scientific support (top)

  • Establishment of medical expert reports for re-registration purpose
  • DSURs, PSURs, see also “drug safety”
  • Writing and up-dating of SmPCs and package inserts