Pharmacovigilance

Pharmacovigilance-related regulatory requirements have been ever increasing in scope and detail. We will help you meet these requirements. Use our custom-made solutions for pharmacovigilance and MedDRA-related issues (Medical Dictionary for Regulatory Affairs; ICH-M1).

• Coding of side effects / diagnoses / diseases / symptoms / laboratory findings using the current MedDRA version
• Recoding of old data
• Updates of “old” MedDRA-coded data
• Preparation of line listings (as specified by the client and guidelines)
• Preparation of PSURs
• Recording and evaluation of SAEs/SUSARs including any required follow-ups
• Reports to authorities
• Preparation of SOPs

All databases are continuously maintained using the current MedDRA version.