Safety & Risk Management
Unparalleled Expertise to Mitigate Risk & Ensure Safety
Integrated, comprehensive solutions to demonstrate safety across the product lifecycle.
UBC combines innovative technologies and epidemiological expertise to help mitigate risk and demonstrate product safety while optimizing the commercialization and delivery of products to market. Leveraging a high-touch, technology-enabled approach to collecting, managing, interpreting, and reporting safety information, we collaborate with customers to ensure the benefits of a drug or biologic outweigh its risk and meet regulatory agency requirements.
Deep Scientific Knowledge
UBC possesses deep scientific knowledge across a broad range of indications including rare and orphan diseases and cell and gene therapies. We understand your needs regardless of whether your product is a new chemical entity, an advanced therapy medicinal product, or a generic or biosimilar. Our expertise and transformative approach to evidence generation creates significant value along the drug development pathway.
Integrated Solutions to Demonstrate the Safe Use of Products
Every UBC program is designed to meet the unique requirements that your product demands. Our consultative approach addresses the critical need to identify the right data for the right purpose and help you make better, more informed decisions to demonstrate safety, efficacy, and value.
Risk Evaluation & Mitigation Strategies
- REMS Consulting & Design
- REMS Implementation & Evaluation
- EU Risk Management Plans & Effectiveness Evaluations
- Full-Service Outsourcing
- Safety Case Processing & Reporting
- Literature Review
- Safety Writing
- Signal Detection & Management
Learn More About UBC's Safety & Risk Management Solutions
Interested in learning more about how UBC’s safety and risk management solutions can help you make more informed decisions earlier and meet regulatory requirements?