PHARMACOVIGILANCE
Entrust your pharmacovigilance concerns in the experienced hands of our Team. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for you.
- Services of EU QPPV, Local QPPV
- Pharmacovilgilance System Set up and Review services
- ICSR management
- On-going monitoring and signal management
- Literature surveillance services
- Risk management
- Reporting
– Product Safety Update Reports (PSURs)
– Periodic Benefit-Risk Evaluation Reports (PBRERs)
– Development Safety Update Reports (DSURs)
– Periodic Adverse Drug Experience Reports (PADERs)
– Risk Management Reports (RMPs) - Safety Data Exchange Agreements
- Pharmacovigilance Quality System, audits and inspections
– Pharmacovigilance System Master File (PSMF)
– Standard Operating Procedures (SOPs)
– Internal and third party audits, mock-up inspections, CAPA writing - Training