Regulatory and Insights Support
Increase efficiency and effectiveness of regulatory applications and regulatory body responses to in-market challenges.
Independent expertise and resources you can trust
Med Safety Board (MSB) solutions are administered by product safety experts who are actual end-user clinicians (e.g., PharmD, RN, MD). In addition to our unique multidisciplinary teams, we formulate advisory boards, convene focus groups, and survey industry clinicians to identify safety concerns, validate best practices, and develop strategies for improving safety in pharmaceuticals and medical devices. Additionally, we analyze medication error reports from across the ISMP and ECRI organizations, along with Food and Drug Administration (FDA) adverse event and error databases, to identify patterns of errors, their underlying causes, and potential safety risks.
Pre-Market and In-Market Regulatory Support
Bolster regulatory submissions and responses with MSB’s expertise in human factors engineering studies, labeling and packaging best practices, clinical data interpretation, known use error research, and other product and patient safety solutions. Our comprehensive solutions identify safety concerns as medical devices, medication-related devices, and pharmaceutical products are developed and in support of regulatory responses when errors occur post approval.
Insights and Qualitative Research
Leverage MSB-assembled clinician advisory boards, focus groups, and surveys to gain insights from key users. This collaborative approach helps to identify potential safety concerns, validate best practices, identify common clinician workarounds, and generate safety improvement recommendations to avoid future errors. MSB establishes goals for analysis; assembles agendas, discussion guides, and questions; hosts and executes ad boards, groups, and surveys; and helps uncover contributing factors to potential risks and develop strategies to address safety concerns in pharmaceutical and device products.
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More Ways We Help
Product Risk Mitigation
Make smarter, research-based decisions by harnessing the power of the world's top medication safety organization.
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Safety Education
Empower your team with tailored safety education, expert-led training, and evidence-based content to enhance compliance and safety.
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