UBC experts in product safety, risk management and epidemiology are
recognized throughout the World and provide comprehensive strategic
consulting services to organizations throughout the life sciences
community. Our experts have designed and implemented many of the
industry’s largest and most complex safety and risk management
programs. In addition to their experience with industry leaders,
most UBC experts participated in the development of regulatory
guidances that continue to drive the priorities of authorities
throughout the World, particularly the U.S. Food & Drug
Administration (FDA) and the European Medicines Agency (EMA).
Our experts can help:
- Identify areas that require risk management
- Design risk management programs to meet regulatory requirements
- Design and implement disease and product registries to meet
regulatory requirements and address commercial objectives
- Examine real-world use of drugs and associated outcomes
- Understand drug safety issues and risk factors at the patient
level
- Prepare safety reports and manuscripts for regulatory, product
marketing, and medical communications
