Medical Consultancy

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Medical Consultancy

“Need for efficacy and safety of the product”


Medical writing of regulatory documentation:

  • Clinical Overview and Summary (all legal basis applications)
  • Non-clinical Overview and Summary (all legal basis applications)
  • Clinical Study Reports (CSRs), protocols, Investigators brochures (IBs), safety narratives
  • Enviromental Risk Assessment
  • SmPC, PIL
  • Bridging reports (readability)
  • Writing of medical / pharmaceutical publicatons for journals

Medical writing in Pharmacovigilance

  • Company Core Data Sheet, Company Core Safety Information
  • Periodic Safety Update Reports (PSUR / PBRER)
  • Risk-benefit reports
  • Signal detection
  • Risk Management Plan (RMP)
  • Medical assessment of adverse drug reactions
  • Medical Enquiries

Medical advising / promotional activities

  • Pre – or post – launch strategic medical/scientific advising
  • Advising on promotional scientific content and communication plan
  • Communication with key opinion leaders on behalf of the customer
  • Preparation for Advisory boards/Expert panels
  • Publication planning and preparation
  • Promotional material preparation