UBC’s regulatory affairs professionals provide comprehensive services targeted to the needs of emerging companies. Our goal is to work collaboratively with pharmaceutical and biotechnology companies to develop innovative, customized, strategic programs that help our clients obtain and maintain the regulatory applications necessary to study investigational drugs and biologics, in pursuit of market approval.
We offer:
- Overall drug development and strategic planning
- Global regulatory strategy preparation and implementation
- Regulatory liaison activities (e.g., submissions, meetings)
- Guidance to support preclinical and clinical research programs
- Regulatory training
In addition, UBC provides a wide array of support services, including medical writing, statistics and programming.
Based on decades of high-level work on a diverse portfolio of projects, we can help emerging companies navigate through the maze of regulations, drawing on our clear understanding of FDA requirements and assisted by our positive relationships with professionals at all levels within the Agency.