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