3- Pharmacovigilance Systems & SOP Development

We support marketing authorization holders (MAHs), manufacturers, and distributors in establishing and optimizing pharmacovigilance systems that meet both local and international regulatory requirements. Our service covers the full spectrum—from setting up adverse event reporting workflows and signal detection mechanisms to developing risk management plans aligned with SFDA, EMA, and GVP module expectations. We also design audit-ready SOPs tailored to your operational model and regulatory environment. Our pharmacovigilance solutions help ensure patient safety, maintain product licensure, and facilitate transparent, compliant engagement with health authorities.