Full Service REMS Solutions

Sponsors often encounter challenges with REMS programs, including limited visibility into program effectiveness, slow issue resolution, vendor quality concerns, and gaps in regulatory expertise. MMS addresses these challenges through an integrated model that aligns people, process, and technology. 

MMS combines regulatory and safety expertise with proprietary REMS-focused technology to support real-time evaluation of risk, program performance, and regulatory readiness. 

As a leading submissions provider and full-service REMS administrator, MMS supports REMS programs across therapeutic areas and development stages, with contributions spanning regulatory strategy, safety risk management, operations, analytics, and technology.

REMS leadership within MMS is strengthened by deep regulatory experience across FDA-facing roles and sponsor partnerships. The REMS team includes safety, regulatory, and quality professionals with extensive experience working hand in hand with the FDA on complex risk management programs. 

This capability is further advanced by:

• Dr. Somya Dunn, Senior Medical Director, Safety Risk Management, who brings nearly two decades of experience in drug safety, regulatory science, and REMS. Dr. Dunn previously served in senior risk management roles within FDA CDER, where she advised on benefit–risk strategy and led the design, implementation, and lifecycle oversight of high-profile REMS programs. 

• Dr. Jeffery Wiese 
• Chrissy Manley 
• Dr. Jennifer Perrin

This leadership enables MMS to support sponsors not only in meeting REMS requirements, but in refining, optimizing, and when appropriate, supporting regulatory pathways toward REMS modification or exit.

MMS supports REMS programs with purpose-built technology that enables real-time safety evaluation, continuous monitoring, and proactive issue resolution. Sponsors gain access to REMS performance data through integrated platforms that support continuous monitoring and proactive management. 

Advanced visualization tools, including Datacise®, enable sponsors to review program metrics, identify trends, and evaluate effectiveness without reliance on static reports or delayed analyses. This approach supports timely decision making and strengthens regulatory interactions throughout the REMS lifecycle.  

Through our tool, sponsors can:  

• monitor REMS performance metrics in near real time,  
• identify emerging risks early, and  
• optimize program effectiveness without relying on static reports or delayed data reviews. 

MMS REMS solutions scale from single or ad hoc program needs to full pipeline partnerships. MMS supports REMS programs from NDA and BLA submission through post-approval, including ongoing effectiveness assessment, program refinement, and regulatory engagement as expectations evolve.  

Our teams support sponsors with the experience, templates, review tools, and operational know-how required to manage REMS across evolving portfolios and aggressive timelines. This scalability allows sponsors to adapt REMS strategies as products mature, risk profiles change, and regulatory requirements evolve.