Drive Consistent Access and Safe Use Conditions for Your Therapy

Our Risk Evaluation & Mitigation Services (REMS) help pharmaceutical companies comply with FDA drug development, launch and ongoing safety reporting requirements.

McKesson has deep expertise in managing the full spectrum of REMS programs, including some of the industry's largest and most complex REMS programs mandated by the FDA. Our experienced faculty of clinical, drug safety, regulatory, pharmacovigilance and data management experts actively assist biopharmaceutical and life science companies through the REMS development processes.


We currently manage risk-management programs across many therapeutic areas, including oncology, opioids, rheumatology, neurology, pain management, cardiovascular, dermatology, gastroenterology, weight management, and men’s and women’s health, among others.

Our expertise and broad range of capabilities enables us to provide customers with a unique, end-to-end REMS solution to help pharmaceutical companies comply with FDA safety requirements while ensuring patients have appropriate access to drugs and biologics. We have what you need to design, implement, and manage all components of REMS, as demonstrated in our wide range of capabilities, including RelayHealth's pharmacy-network REMS service.


  • Consulting services: FDA submissions, strategic program designs, and more
  • Expert teams: professional and friendly teams including Implementation, Project Management Office, and Account Management, who execute program best practices
  • Database integration & management: validated platform serving as central database of record for patients, healthcare professionals, healthcare settings, and pharmacy enrollment capabilities
  • Award-winning patient-support services: largest single-site U.S. healthcare services call center, certified as a Center of Excellence by BenchmarkPortal and Purdue University's Center for Customer-Driven Quality
  • Risk monitoring and clinical data collection: by highly trained clinical staff
  • Surveys and assessments: assessment of program effectiveness through patient, healthcare provider, healthcare setting, and pharmacy surveys
  • Coordination: with commercial reimbursement/patient access support services, as needed
  • Distribution models: full range of distribution models for programs with restricted access that facilitate REMS product alignment with appropriate commercial channels
  • Real-time pharmacy integration: ability to integrate within retail pharmacy workflows in real time
  • Monitoring & auditing: rigorous program compliance monitoring and auditing services


  • Reduce likelihood of drug launch delays by planning early and leveraging McKesson's experience in designing and obtaining FDA approvals of REMS programs
  • Increase program efficiency by working with a partner that can meet all of your REMS needs from program design, to implementation, to maintenance, to FDA reporting
  • Opportunity to ease the burden on physician offices by integrating REMS and reimbursement/access program services and creating a "one-stop-shop" for customers
  • Ensure adverse events are captured and tracked appropriately per your defined process in McKesson's validated environment
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  • What is REMS?

    REMS is defined by the FDA as a program to manage a known or potential serious risk associated with a drug or biologic product. A REMS program may include:

    •  Medication guide 
    •  Communication plan 
    •  Elements to assure safe use 
    •  Implementation system 
    •  Restricted distribution 
    •  Timetable for assessment 

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    Learn more about McKesson solutions for biopharma and life sciences companies.

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