2. Pharmacovigilance

Our safety management services include, but not limited to:

  • Pharmacovigilance  management for registered medicinal products
  • Development of Pharmacovigilance Master File
  • Development of PSUR
  • Development of Risk Management Plan
  • Adverse event handling
  • Development of clinical safety documents
  • SAE reporting management
  • Safety reporting to Regulatory Authorities of Republic of Armenia / Ethics Committee
  • Local and international literature monitoring

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