We Help Define Pharmacovigilance Expectations, Not Just Follow Them
When it comes to local pharmacovigilance, credibility matters. Our experts have contributed to international pharmacovigilance guidelines and work closely with health authorities and regulated companies to translate regulatory expectations into real-world practice.
If you operate across multiple countries, local pharmacovigilance is where complexity turns into risk, often revealed during an inspection. Responsibilities blur, national requirements are interpreted differently, and local practices drift from global processes, creating gaps that are difficult to defend.
If you operate across multiple countries, local pharmacovigilance is where complexity turns into risk, often revealed during an inspection. Responsibilities blur, national requirements are interpreted differently, and local practices drift from global processes, creating gaps that are difficult to defend.
Country-Level Pharmacovigilance Support That Closes the Gaps
Local pharmacovigilance only works when responsibilities are clear, activities are consistent, and expectations are understood at country level. Our Local PV Network provides practical, on-the-ground support to help you meet national requirements, maintain continuity, and stay inspection-ready across every market you operate in.
Responsible Person at Country Level and Deputy
You need assurance that local pharmacovigilance responsibilities are always covered. We provide qualified Responsible Persons at country level, supported by trained deputies to always ensure continuity. Our local experts act as your official point of contact with authorities and ensure national safety requirements are met accurately and on time.
Compliance at Country Level
Local pharmacovigilance compliance must be clear and defensible. We support compliance with national PV legislation, guidance, and authority expectations in each country where you operate. Our local experts translate regulatory requirements into practical actions and help you maintain a compliant, inspection-ready local PV system.
Supporting Case Intake and Follow-Up
Accurate and timely case handling is essential for patient safety and compliance. We support local case intake and follow-up activities in line with country-specific requirements. Our experts ensure adverse events are captured correctly, relevant information is obtained efficiently, and cases are managed in accordance with local expectations.
Supporting Process of ARMM:
Risk minimisation measures require consistent and compliant local execution. We support the implementation and maintenance of Additional Risk Minimisation Measures (ARMMs) in line with national authority requirements. Our local experts help ensure ARMM activities are practical, documented appropriately, and ready for inspection.
Supporting Local Inspection and Audit Readiness
Inspection readiness should be continuous, not reactive. We support local inspection and audit preparedness by ensuring documentation, processes, and local PV systems meet authority expectations. Our experts understand how regulators assess compliance and help you respond confidently before, during, and after inspections.
