REMS Development

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Business & Decision Life Sciences is able to develop Risk Evaluation and Mitigation Strategies (REMS) for pharmaceutical and medical device clients, leveraging a number of tried and tested risk management techniques.

With a long track record in risk management and with tried and tested techniques used to manage multiple, complex Enterprise Risks (see Enterprise Risk Management), Business & Decision Life Sciences combines leading risk management techniques with an understanding of drug and device safety to assist clients to develop REMS programs and to manage the development of REMS roadmaps.

Most importantly, our understanding of the risks associated with different drug / device profiles and classes allows us to ensure that all risks are considered and appropriately mitigated. This not only meets increasing regulatory expectations for proactive risk management approaches but also cost effectively reduces any potential risk to patients.

Our expertise in managing enterprise level risk management programs also ensures that REMS are developed efficiently, leveraging best practice risk management techniques with cost effective approaches to enterprise risk management. Programs are monitored and managed to ensure that objectives and timescales are met and that risk mitigation activities are scaled to provide appropriate return on investment and effective reduction of risk to patients.

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