EU Risk Management Plans (RMP) and US REMS Preparation and Submission Services
When applying for a marketing authorization, all pharmaceutical companies should submit RMP (Risk management plan) to the European Medicines Agency (EMA) and similarly REMS (Risk Evaluation and Mitigation Strategy) for USFDA review and approval for certain drug or biological product to ensure that the benefits outweigh the risks.
An RMP is constantly modified and updated throughout the lifetime of the medicine as and when there is an important safety concern about a risk affecting the benefit-risk ratio or when new safety information becomes available from health authority or safety committee.
RMPs consists of the product safety profile along with concerned safety concerns (Important identified/ potential risk and missing information), their preventive and minimization measures (routine and additional) and how effectively they are implemented by measuring their effectiveness.
iSafety provides companies with the following Risk Management and support services.
The core processes and services include:
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