Synowledge’s pharmacovigilance compliance assessment measures a company’s PV operations against the requirements of all applicable regulatory bodies, reviews company practices across the product lifecycle, inspects detailed documentation on case processing, evaluates related information of systems and documents, identifies failures and gaps within processes, and recommends improvements and remediation. Once this assessment is completed, Synowledge can provide a gap analysis and prioritize solutions to mitigate and remove identified risks.
- Pharmacovigilance strategy
- Results of FDA or other third party assessments
- Structure of the company's pharmacovigilance organization
- Interfaces, linkages, and communication
- Pharmacovigilance processes and Standard Operating Procedures
- Tools utilized in assessing, analyzing, and reporting safety data
- Safety surveillance and signaling activities for compliance with good pharmacovigilance practices