Marketing authorisation: "Exploitation", hosting and maintenance

Medipha Santé accompanies you with :

  • Strategy
  • Compliance with the requirements for every type of variation
  • Preparation of supporting documents
  • Submission of variations according to the appropriate procedure
  • Renewals
  • Pharmacovigilance (Medipha Santé can provide the function of “local QPPV”)
  • Management of the sunset clause (AMM)
  • Literature watch
  • Regulatory monitoring
  • Implementation of Safety Data Exchange Agreement (SDEA)
  • Maintaining the local PSMF
  • Maintenance of opening authorizations, BPD certificate