It is described as a risk management system that contains data concerning the risks identified, possible risks, and missing information about a drug. It significantly outlines any measures to mitigate risks involved and provides information regarding effective monitoring of these measures. Moreover, for every new applicationof products within the European Union (EU), Risk Management Plan (RMP) is required to be submitted to the European Medicines Agency (EMA).
We excel in providing additional risk minimisation and risk management services to help pharmaceutical and biopharmaceutical companies, catering to their safety concerns. These services include creating targeted questionnaires, planning and implementing educational documents and post-authorisation safety studies (PASS) for better risk mitigation.
The professionals at Drug Safety Solutions are equipped with extensive experience with Risk Management Plan services. We also assist with older products that necessitate an RMP now. Although having this sorted out is a challenge as the data needed to fulfil the required sections as the new EU template are generally not available. Even then, our experts can professionally assist you with the assessment procedure regarding the effectiveness of any risk mitigation measures that are needed as per the RMP.
Contact our experts have worked very closely with many pharmaceutical and biopharmaceutical companies, supporting their drug programs and catering to their risk management plan RMP needs. Our extensive experience allows us to efficiently explain our clients’ message consistently and clearly for their intended regulatory obligations!