UBC’s regulatory team is led by experienced scientists with PhDs, MDs and PharmDs who provide the guidance and problem-solving skills needed to navigate the evolving regulatory landscape. With an average of two decades of experience inside the pharmaceutical industry we have a strong foundation for strategic direction and leadership.
We develop and implement innovative, customized, strategic programs that help optimize the development of investigational drugs and biologics, or expand the market potential for existing marketed pharmaceuticals.
We do this by:
- Developing and implementing global regulatory strategic plans to document registration requirements and evaluate development options.
- Managing all regulatory liaison activities, including submission preparation, health authority meetings and query responses
- Providing ongoing advice to development teams to support preclinical and clinical research programs, including guidance on emerging safety issues.
- Determining pathways to broaden commercial potential for marketed products.
- Training both regulatory and non-regulatory professionals on registration requirements and strategy.
- Supporting due diligence activities for in-licensing out out-licensing.