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