Post-Market Surveillance & Pharmacovigilance

Post-Market Surveillance & Pharmacovigilance

Regulatory approval is not the end—it's the beginning. PPB requires annual renewals. SAHPRA requires post-market surveillance plans. Both expect you to catch and report adverse events. Most companies handle this reactively (an event happens, they scramble). We help you stay ahead.

We manage product renewals and retentions across markets, ensuring your approved products stay active. We design pharmacovigilance systems appropriate to your product risk profile—serious medicine might need quarterly safety reports; cosmetic product might just need an annual summary. We track safety data, prepare periodic safety update reports (PSURs), and coordinate with regulators on serious adverse events when they occur.

We also advise on variations to approved products—if you want to change the manufacturing site, reformulate, or expand indications, each requires regulatory notification or approval. We manage that process.