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Our company can provide outsourcing service to pharmacovigilance (PV), or establish integrated services such as pharmacovigilance system, training, pharmacovigilance standardization system (at the same time support CFDA, FDA, EMA standard), medical support for adverse reactions (ADR), etc.
H&J has connected with National Drug Administration and partial CDE data with safety reporting (ICH E2B) standard. one button automatically report CFDA and EMA, FDA. At the same time, support multilingual reporting.
We can provide the following services for enterprises in pharmacovigilance:
Establishment and management of pharmacovigilance system
Collection, assessment and reporting of adverse events
Risk benefit assessment of drugs
Clinical safety report and periodic safety update report
Writing case descriptions
Risk management system
Drug complaint management
Medical monitoring & document monitoring
E2B security data conversion