Pharmacovigilance
We provide a wide range of high-quality global Pharmacovigilance/safety solutions. We have operationally excelled teams to provide customized solutions across the Good Pharmacovigilance Practice (GVP) in relevant health authority requirements.
Regulatory Intelligence – Regular review of authority guidance on the safety requirements in a country or region.
Quality management & Learning – We provide support on setting up of an organization from the beginning and also provide services to improve their QMS for the regulatory compliance. We also provide services on advanced learning methodology.
QPPV & PSMF support: the set up and maintenance of complex global PV systems. Our QPPVs can provide general pharmacovigilance consultancy in addition to the QPPV ‘oversight’ role and can effectively advise on additional pharmacovigilance/risk minimization activities over the life cycle of your product(s).
Health Authority Reporting Requirements & Notifiable scenarios: Provide services to support the organization to be fully compliant on reporting requirements in both Pre-Clinical and Post Marketing environment.
Individual Safety Case Report (ICSR) management including follow up activities: End to end management of safety information as per the industry practice and regulatory standards.
Literature surveillance: Our dedicated literature surveillance team performs end-to-end literature safety surveillance activities that support both clinical trial and post-marketing activities, including ICSR detection and review for signal detection purposes.
Quality management & Learning – We provide support on setting up of an organization from the beginning and also provide services to improve their QMS for the regulatory compliance. We also provide services on advanced learning methodology.
QPPV & PSMF support: the set up and maintenance of complex global PV systems. Our QPPVs can provide general pharmacovigilance consultancy in addition to the QPPV ‘oversight’ role and can effectively advise on additional pharmacovigilance/risk minimization activities over the life cycle of your product(s).
Health Authority Reporting Requirements & Notifiable scenarios: Provide services to support the organization to be fully compliant on reporting requirements in both Pre-Clinical and Post Marketing environment.
Individual Safety Case Report (ICSR) management including follow up activities: End to end management of safety information as per the industry practice and regulatory standards.
Literature surveillance: Our dedicated literature surveillance team performs end-to-end literature safety surveillance activities that support both clinical trial and post-marketing activities, including ICSR detection and review for signal detection purposes.
Non interventional Study support
PLPA/Compassionate use
Aggregate reporting: full range of aggregate safety report and risk management plan writing capabilities to meet both your clinical trial and post-marketing needs (e.g. DSUR, PBRER, PADER, EU-RMP). By deploying a specialized team of safety writers who work across a broad spectrum of document types and therapeutic areas, we ensure that only employees with the most appropriate skillset and experience support this critical task.
Signal detection
Risk management plans & Additional risk minimization activities (ARMMS)
Inspection readiness & PV auditing: Expert PV auditors to advise and recommend an organization fully compliant and ready for an inspection. We provide support on for-cause and routine audits for organization for their commitment to GVP and improvements.
Digital media/channels screening/monitoring: Wide range of solutions to monitor corporate and digital platforms of an organization for safety related matters.
Inspection readiness & PV auditing: Expert PV auditors to advise and recommend an organization fully compliant and ready for an inspection. We provide support on for-cause and routine audits for organization for their commitment to GVP and improvements.
Digital media/channels screening/monitoring: Wide range of solutions to monitor corporate and digital platforms of an organization for safety related matters.
