Supporting Safe Use of Products from Trial Through Commercialization

UBC’s epidemiology-led Safety & Risk Management team provides a wide range of services to support your therapy’s approved and safe use.

We leverage enhanced technologies and product innovations to help mitigate safety risk while optimizing the commercialization and delivery of products to market.

• Guiding manufacturers in meeting FDA requirements to ensure the benefits of a drug or biologic product outweigh its risks
• A high-touch scientific approach to collecting, managing, interpreting, and reporting safety information associated with clinical trials and post-marketing studies
• Support regulatory agency interactions

Safety & Epidemiology Consulting

Our expert team specializes in global clinical, regulatory, risk management, data management, and epidemiology strategy, as well as program design and implementation.

Risk Evaluation & Mitigation Strategies (REMS)

UBC is the premier provider of REMS services. Our unparalleled experience allows us to expertly design and execute your REMS program, manage regulatory interactions, conduct KAB surveys, and provide project management services.

Risk Management Plans

Find out how our design and implementation of complex RMPs in Europe and globally can help your product.

Pharmacovigilance

UBC’s standalone pharmacovigilance team excels at handling every aspect of your safety requirements at all stages of the drug lifecycle. Talk to us about your:

• Safety Database Hosting
• Case Processing
• Literature Screening
• Signal Detection and Assessment
• European Services
• Risk Management
• Safety Writing