•  
     
    Regulatory
    Regulatory

    We’ve got your back. Developing strategies, representing sponsors, and writing and submitting filings to regulatory authorities is our bread and butter.

  •  
     
    Clinical
    Clinical

    Thousands of operational details must be managed to ensure your development programs deliver results. We keep your strategies moving and under control.

    Clinical Development Plan Support

    Biopharmaceutical company developing a revolutionary class of drugs using novel technologies was transitioning their lead compound from research to development and needed clinical leadership to drive program development, planning, and execution.
  •  
     
    Interim Management & Expertise
    Interim Management & Expertise

    When a critical skillset is missing, we fill in the gaps to keep the program chugging along.

    On-Demand Development Team

    A completely virtual biotech company initially needed a partner to advise them on the drug development process and development planning. The relationship continued to expand as development progressed.

Meet the Build team leads

Greg Dombal
President, Chief Operating Officer
Katie McCarthy
Chief Development Officer, Managing Director
Kim Raymer
Vice President, Regulatory Affairs
Jason Milovanovic
Vice President, Clinical Development & Operations
Sheila Gwizdak
Vice President, Quality