The integration of proprietary REMS-focused technology applications, with longstanding expertise in regulatory affairs and a commitment to advancing patient safety, establishes MMS as a leading REMS provider in the space. This strategic expansion, along with the integration of proprietary REMS-focused technology applications, reinforces the longstanding expertise in regulatory affairs and commitment to advancing patient safety through innovative safety and risk management solutions.
“With our deep regulatory expertise and strong track record of success, MMS is uniquely positioned to help sponsors navigate the complexities of REMS with efficiency and confidence,” said Dr. Sharma. “This area needs regulatory and safety expertise to evaluate risks real-time, which MMS is uniquely positioned to accomplish with our proprietary technology and regulatory expertise to mitigate and even exit REMS. We do this while maintaining the highest level of compliance, patient safety, and prescriber habit re-enforcement at all times.
For nearly two decades, MMS has been a trusted partner in regulatory strategy, data science, and regulatory writing, helping life sciences companies achieve compliance and approval success. This latest tech-enabled real-time evaluation of safety with REMS solutions builds on that legacy, ensuring that sponsors have the following support:
· End-to-end solutions that streamline the design, implementation, and ongoing management of REMS via our white-glove PMO capabilities
· Regulatory and safety experts who partner with sponsors at the NDA/BLA submission stage to create tailored, data-driven REMS strategies for brands to ensure FDA compliance.
· Advanced technology and real-time data visualization through Datacise® to empower sponsors in monitoring and optimizing REMS programs.
· Simplified REMS processes by integrating comprehensive regulatory support with proactive issue resolution and strategic risk management insights.
“REMS compliance requires strategic planning, continuous monitoring, and expert regulatory guidance to ensure patient safety and program effectiveness,” said Christine Manley, REMS Director, MMS. “With our enhanced full-service REMS solutions, we are providing pharmaceutical and biotech sponsors with the right technology, expertise, and proactive support needed to effectively navigate FDA requirements and build sustainable, high-impact risk management programs.”
To mark this occasion, MMS has released a free eBook titled, The REMS Playbook: Strategies for Effective Risk Management in Drug Safety. Download a copy at https://www.mmsholdings.com/rems-playbook-strategies/ and learn more about REMS solutions at MMS here: https://mmsholdings.com/solutions/safety-risk-management/.
About MMS
MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, an 18-year track record, AI technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating.
For more information, visit www.mmsholdings.com.
Media Contact
Don F. McLean, dmclean1@mmsholdings.com
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