Restoring PSUR & RMP Compliance Across High-Risk Markets

In this case, required PSURs had not been submitted in multiple countries and the client lacked visibility of local reporting obligations across Africa and Asia. PrimeVigilance conducted a Regulatory Intelligence review, mapped local requirements and created a harmonized global submission schedule to restore control and regulatory visibility.

Key outcomes 

• Compliance restored across multiple regions
• Harmonized submission management
• Sustainable PSUR/RMP governance established
• No major findings during regulatory inspections

From Compliance Gaps to Sustainable Regulatory Oversight

Download the case study to see how Regulatory Intelligence, Medical Writing, Local QPPVs and Project Management worked within one governance model to restore PSUR and RMP compliance.