Risk Evaluation & Mitigation Strategies
Positively Impact and Manage Your Product’s Safety
Market-efficient strategies to manage risks and regulatory obligations.
Fulfill Your Regulatory Obligations With Confidence
Regulatory requirements for new and existing products can be complex and require proven methods, extensive knowledge, and technical expertise. A trusted partner who can provide guidance on meeting FDA mandates to ensure the benefits of a drug or biologic product outweigh its risk can make all the difference.
REMS Consulting & Design
Whether a REMS plan is on the horizon, or you are currently in discussion with the FDA, UBC offers consulting on all aspects of your REMS program and FDA interactions. Regardless of your timing requirements, we can partner at any point to review product benefit and risk, provide REMS design options, and ensure you are ready for REMS discussions as you move through product development and approval.
With over 150 years of combined industry experience rooted in evidence generation, our REMS consultants provide strategic guidance to support customers in securing the safe and appropriate use of their products. The UBC epidemiology-led approach supports regulatory authority interactions regarding effective strategies for mitigating specific product risks.
REMS Implementation & Evaluation
Partner with a trusted advisor for full-service REMS delivery
With experience delivering more than 140 risk management programs across multiple therapeutic areas with varied risks, UBC is the leading provider of integrated, comprehensive REMS services. Guided by our team of epidemiologists, safety scientists, clinicians, data analysts, software developers, statisticians, psychometricians, and project managers, UBC has established a reputation among sponsors and the FDA as the leader in full-service REMS delivery.
- REMS Implementation
- UBC Knowledge Survey System
- Coordinating Center Operations (REMS Center of Excellence)
- REMS Evaluation
- FDA Assessment Report Analysis and Preparation
Configurable, Scalable Solutions
When a multi-sponsor REMS consortium is required, it is important to establish consensus on imperatives among the sponsors comprising the single, shared system REMS. By applying UBC’s deep REMS experience in conjunction with the project management organization
(PMO) offering, customers benefit from a centralized approach ensuring both consortium and individual company requirement consideration in a professional, confidential, and fiscally responsible manner.
UBC as PMO:
- Governance & Program Charter
- Sponsor & Third-party Vendor Onboarding
- Regulatory Reporting Oversight
- Document Repository Management
- Financial Planning & Management
REMS Experience
EU Risk Management Plans & Effectiveness Evaluations
Your guide to understanding, evaluating, and mitigating product risk
With an increasing regulatory focus on the importance of evaluating the effectiveness of risk minimization activities, UBC is uniquely skilled at
designing and implementing evaluation studies with maximum efficiency and minimal burden to healthcare professionals, patients, and sponsors.
UBC is unequaled in its mastery of Risk Management Plan (RMP) requirements, leveraging experts who have created complex RMPs, not only in the EU, but also in other territories worldwide where an RMP is required for regulatory approval. We are well-versed in local regulatory requirements, and we understand the nuances of these regulations and how RMP content is interpreted. UBC partners with you to develop an RMP that will meet regulatory expectations and
minimize questions during the regulatory review period.
EU Risk Management Services:
- Developmental RMPs
- Assessment of Effectiveness of Additional Risk Minimization Measures (aRMMs)
- RMPs for Regulatory Submission
- Protocol Development for Post-Authorization Safety Studies
- Risk Minimization Activities and Educational Materials
EU Risk Management Experience
Frequently Asked Questions
Will my product need a REMS?
Not every drug needs one. A REMS is mandated when a regulator believes the benefits of a drug or biologic outweigh its risks but still requires structured oversight to ensure safe use. The likelihood depends on the mechanism of action, indication, and what’s already known about similar molecules. UBC’s epidemiology-led consulting team reviews your benefit-risk profile and helps you understand whether a REMS is on the horizon, what its likely complexity would be, and what to prepare for ahead of FDA discussions.
What does a REMS programme actually involve?
Most REMS centre on Elements to Assure Safe Use (ETASU) — a defined set of requirements regulators apply to prescribers, pharmacies, healthcare settings or patients, depending on the risk being mitigated. Programmes can be lightweight (medication guides, communication plans) or restrictive (prescriber certification, lab confirmation, pharmacy verification, patient registries). UBC has administered programmes with one through six ETASU and designs each one around the specific risk being addressed — not a generic template.
How do I decide between a lightweight and a comprehensive REMS?
That decision is shaped by FDA dialogue, the risk profile of the product, and how confidently you can demonstrate safe use without restrictions. UBC works through three postures with sponsors — full-complexity, mid-complexity, or wait-and-see — so the leadership team can choose a position based on commercial appetite, the evidence already in hand, and what the agency is signalling. The point isn’t to pick the biggest plan; it’s to choose the right one and know why.
What experience does UBC have running REMS?
UBC has delivered more than 140 risk management programmes across multiple therapeutic areas and currently administers over 50% of active REMS with one to six ETASU. The team has submitted over 100 REMS Assessment Reports to the FDA and completed more than 18,000 Knowledge, Attitude & Behaviour surveys — the evaluations regulators use to judge whether a REMS is achieving its goals. That depth shows up in how the team reads FDA signals, not just in the volume itself.
Can UBC support EU Risk Management Plans as well?
Yes. UBC has more than 14 years of EU Risk Management Plan experience, with over 70 RMPs in the EU and over 20 in other jurisdictions where an RMP is required for approval. The work covers developmental RMPs, additional risk minimisation measures, post-authorisation safety study protocols, educational materials, and effectiveness evaluations. Most clients need a globally coherent narrative rather than separate documents — that’s where the team works hardest.
What happens when a REMS involves multiple sponsors?
Shared-system REMS — common for drugs in the same class — require sponsors to agree on a single set of obligations. UBC’s project management office handles governance, third-party vendor onboarding, regulatory reporting oversight, document repository management, and financial planning across the consortium. The aim is for each sponsor to be heard while the consortium operates cleanly enough that FDA sees one programme, not three.
How does UBC's contact centre handle REMS calls?
The REMS Coordinating Centre handles more than 25,000 calls per month, with 88% of inbound calls answered in under 30 seconds. Staffing models are tuned to the call mix — prescribers verifying certification, patients confirming eligibility, pharmacies clarifying dispensing rules. The team blends trained agents with workflow automation rather than treating it as either-or, because some moments need a human and others don’t.
Learn More About UBC's REMS
Interested in learning more about how UBC’s REMS can help you make more informed decisions earlier and meet regulatory requirements?
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Bekki Bracken Brown
President & Chief Executive Officer
Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.
With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.