Safety & Risk Management
Reassurance for the real world
We build confidence for prescribers by providing unmatched expertise in patient safety, along with strategies and results that balance commercial goals with seasoned regulatory oversight.
Driven to Ensure Patient Safety at the Forefront of Innovation
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. Our drug safety and global risk management solutions encompass the full product lifecycle, including comprehensive post-marketing surveillance and regulatory affairs support. Leveraging a high-touch, technology-enabled approach to collecting, managing, interpreting, and reporting drug safety information, we collaborate with customers to ensure the benefits of a drug or biologic outweigh its risk and are regulatory compliant.
Deep Scientific Knowledge
UBC possesses deep scientific knowledge across a broad range of indications and modalities 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 pharmacovigilance and REMS planning creates significant value along the drug development pathway.
Integrated Solutions to Demonstrate the Safe Use of Products
We execute data-driven safety and risk management solutions to minimize patient risk. 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. With decades of experience in REMS planning, we help our partners manage risks and regulatory obligations with confidence, while our tenured drug safety expertise provides unmatched insights for informed pharmacovigilance decisions every step of the way.
Risk Evaluation & Mitigation Strategies
- REMS Consulting & Design
- REMS Implementation & Evaluation
- EU Risk Management Plans & Effectiveness Evaluations
Pharmacovigilance
- Full-Service Outsourcing
- Safety Case Processing & Reporting
- Literature Review
- Safety Writing
- Signal Detection & Management
Learn More About UBC's Evidence Development Strategic Approach
Interested in learning more about how UBC’s evidence development strategic approach can help you unite evidence and access to inform complex decisions?
