At Jeyflex, we specialize in the development and implementation of robust Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for pharmaceutical products. Our services encompass the complete lifecycle of risk management, from initial writing and submission to ongoing tracking and evaluation of effectiveness.
Understanding the RMP
A Risk Management Plan (RMP) is a detailed document that outlines the risk management system associated with a particular pharmaceutical product. It provides comprehensive insights into identified risks, potential risks, and any information gaps. Moreover, it includes a detailed outline of adopted risk minimization measures and continuous monitoring and assessment methods to ensure their effectiveness.
Additional Risk Minimization Measures (aRMM)
As part of our comprehensive risk management solutions, we offer Additional Risk Minimization Measures (aRMM) as part of their risk management solutions, tailored to address specific safety concerns. Their services include:
- Customization to align with local regulatory requirements.
- Meticulous preparation of submissions for approval by Health Authorities.
- Targeted distribution to relevant stakeholders.
- Diligent tracking and assessment processes to ensure the effectiveness of implemented measures.
Pharmacovigilance Activities Partner in Africa and Beyond
Our pharmacovigilance activities extend beyond documentation and compliance. We focus on the practical application of risk management, incorporating vital information into Product Information Leaflets (PILs), conducting Post-Authorization Safety Studies (PASS), and facilitating educational and support programs for healthcare professionals and patients.
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Partner with Jeyflex to ensure a comprehensive and effective risk management strategy for your pharmaceutical products, addressing potential risks and enhancing overall safety and compliance.
Our solutions are tailored to meet your unique needs and requirements, whether you’re a small startup or a large multinational corporation. We offer a range of services, including, consulting, training, and auditing, to help you ensure that you are complying with relevant regulations and laws, and to minimize the risk of non-compliance.