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Strategic Consulting: REMS and safety services

Envision Pharma’s Strategic Consulting group partners through the critical stages of development, launch planning, launch, and product acceleration to create value. Powered by technology, our team of experts develop solutions that meaningfully improve strategies, tactics, operational effectiveness, and outcomes.

REMS and safety services

Through our REMS services, we deliver tailored strategies and solutions to navigate the complexities of REMS programs and safety requirements, streamlining operations, mitigating risks, and optimizing REMS strategy.

REMS and safety services


We understand that navigating risk evaluation and mitigation strategy (REMS) programs, risk management plans (RMPs), controlled access programs (CAPs), and other drug safety requirements can be complex and time-consuming. Our team of experienced professionals brings a deep understanding of regulatory requirements and a proven track record of success in developing and implementing drug safety programs and strategies. Through our comprehensive understanding of the drug safety landscape, we provide strategic guidance and tailored solutions that address your product’s unique needs.

Maximizing access to your therapy

By partnering with us, you gain access to a comprehensive range of services designed to maximize access to your therapy while also supporting safe use.

Situation analysis and strategy

The best business decisions are informed by data and experience. Our drug safety experts partner with clients to understand the risks and risk mitigation requirements associated with your product so that you can be prepared for the possibility and reality of extra safety requirements, such as REMS and CAPs. Our strategies are carefully designed to fulfill your goals, cater to product-specific demands, foresee potential challenges, and swiftly adapt to any obstacles that may emerge.

REMS and CAP administrator services

A strategy is only as good as the system, processes, and people that bring it to life. We partner with clients to streamline your safety program requirements and operations with our comprehensive suite of administrator services. From patient enrollment to tracking and reporting, we manage every aspect of your safety program with precision and efficiency.

Submission documentation and negotiation support for REMS

Our team excels in drafting regulatory documentation for inclusion in drug applications, meticulously ensuring compliance with applicable regulatory standards, as well as best practices. We provide expert negotiation support with regulatory authorities and stakeholders to mitigate risk effectively while minimizing stakeholder burden.

Program management and operational oversight

Trust us to manage and oversee your REMS program, ensuring regulatory compliance and program effectiveness. Our team guarantees seamless compliance and operational excellence throughout the product’s life cycle.

KAB surveys and assessment reports

By conducting knowledge, attitudes, and beliefs (KAB) surveys, you gain insights into program impact and areas for improvement, promoting patient safety and continuous advancement.

What's your problem?

We hold unique expertise that can tackle your biggest challenge, anticipate the next challenge, and build bespoke solutions.