Risk Management Planning and Benefit–Risk Evaluation

At Dr. Mwiko Health Solutions Ltd, we specialize in designing and implementing comprehensive Risk Management Plans (RMPs) and benefit–risk evaluation strategies that ensure patient safety, regulatory compliance, and product success across the product lifecycle. Our approach integrates clinical evidence, real-world data, and regulatory insight to help clients proactively identify, assess, and mitigate product-related risks.

We work closely with pharmaceutical, biotechnology, and medical device companies to develop fit-for-purpose risk management frameworks that not only meet regulatory expectations but also enhance confidence among healthcare professionals and patients.

Our Risk Management Services Include:

• Development and maintenance of Risk Management Plans (RMPs) in alignment with EMA, FDA, and African regulatory authority guidelines
• Preparation and periodic updates of Risk Minimization Measures (RMMs) and Educational Materials
• Support in Signal Evaluation, Safety Concern identification, and Benefit–Risk assessment during both clinical and post-marketing phases
• Integration of risk management strategies into clinical development, labeling, and post-authorization activities
• Medical writing and scientific documentation of risk management deliverables and safety summaries
• Regulatory submission support, ensuring RMPs and related documentation meet regional and global requirements

Benefit–Risk Evaluation and Strategy

We apply a structured, evidence-based methodology to assess the evolving safety and efficacy profile of medicinal products. We critically evaluate clinical trial data, spontaneous reports, and real-world evidence to provide a balanced, transparent assessment of benefits versus risks.

Through this process, we help clients:

• Maintain regulatory compliance with ICH E2C(R2) and GVP Module V guidelines
• Strengthen decision-making for product labeling, lifecycle management, and portfolio strategy
• Demonstrate ongoing product value and safety to regulators, payers, and healthcare professionals