DEVPRO BIOPHARMA IS A CLINICAL RESEARCH AND DEVELOPMENT ACCELERATOR WITH THE MISSION TO DESIGN, DEVELOP, AND DELIVER MOLECULES INTO MEDICINES.
Our corporate vision is to be a force for continual change in clinical development, focused on bringing medicines to people faster and more efficiently.
DEVPRO BIOPHARMA’S UNIQUE CAPABILITIES ALLOW THE TEAM TO SPAN FULL DEVELOPMENT PROGRAMS, WITH FOCUS ON THE COMPLETE DEVELOPMENT CYCLE THROUGH GLOBAL REGULATORY APPROVALS.
OUR EXPERTISE:
- Leading clinical programs and studies from protocol design through product approval, including clinical safety management, regulatory strategy, and inspection readiness
- Accelerating products to market, relative to competitors and standard pharmaceutical development timelines
- Managing both privately held and public organizations
- Navigating and excelling in a large, global pharmaceutical environment
- Global development and product approval across U.S., Europe, Asia, Latin America, as well as emerging markets, such as China
- Leading major regulatory sponsor inspections in U.S., EU, China, Japan
- International regulatory submissions and negotiation with regulatory bodies (FDA, EMA, PMDA, MHRA, Health Canada, TGA, NMPA, and more)
- Funding, building, and managing a start-up company