All marketing authorisation Holders need someone to take good care of drug safety. Dr. Haney Pharma offers tailored services from complete pharmacovigilance systems to individual counselling, report writing, case study reporting or other tasks related to drug safety.

Here are some examples:

  • New creation or update of pharmacovigilance system master file
  • Creation and update of standard operation procedures
  • Pharmacovigilance staff training at client’s facility
  • Provision of a qualified person for pharmacovigilance (QPPV) with 24/7 availability on the phone
  • Answering enquiries with medical and technical information
  • Literature search and analysis
  • Signal detection
  • Periodic safety update reports (PSUR)
  • Benefit-risk evaluation
  • Development of risk minimisation measures
  • Risk-management plan
  • Clinical expert statements
  • Safety reporting
  • Adverse effects reporting
  • EudraVigilance set-up and reporting
  • Suggestions on how to adapt the product information (patient information leaflet, a summary of product characteristics, brochures for advertising, educational material)
  • Pharmacovigilance audit preparation and support during an audit