WE DESIGN, DEVELOP, AND DELIVER
MOLECULES INTO MEDICINES

OUR CORPORATE VISION
is to use our unique model, focused on innovation, flexibility, and efficiency, to bring medicines to people faster

Clinical Studies

Our UNIQUE CAPABILITIES and SUCCESSFUL TRACK RECORD allow the team to span full development programs, with a focus on the complete development cycle through global regulatory approvals.

We continually reimagine clinical trial development and execution by leveraging our partnerships and experience with the goal of improving quality, de-risking development path, accelerating timelines, and lowering costs.

Our team has collectively contributed to more than 50 approved products or label expansions spanning multiple therapeutic areas across the globe over the past 30 years.

An example of our successful teamwork includes BEVESPI AEROSPHERE® and BREZTRI AEROSPHERE™, approved in several key markets including the U.S., China, and Japan.

BEVESPI AEROSPHERE® is a registered trademark of AstraZeneca PLC. BREZTRI AEROSPHERE™ is a trademark of AstraZeneca PLC.

Experienced clinical study team

OUR EXPERTISE

  • Experience funding, building, and managing a start-up company
  • Successful product approvals on programs and studies led from protocol design to market
  • Navigating and excelling in a large, global pharmaceutical environment
  • Global development and product approval across the U.S., Europe, Asia, Latin America, as well as emerging markets such as China
  • International regulatory submissions and negotiation with regulatory bodies (FDA, EMA, PMDA, MHRA, Health Canada, TGA, NMPA and more)
  • Leading major regulatory sponsor inspections in the U.S., EU, China, Japan
  • Managing both privately held and public organizations