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We are scientists, researchers, strategists, and innovators on a mission to help innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics for patients.
About Us
Strategic Product Development Solutions
Across the development lifecycle, our integrated solutions and cross-functional team provide customized support for your program—from the earliest stages of strategy and planning through regulatory approval to commercialization.
Strategy
Drive regulatory and commercial success for your drug, device, or combination product through a comprehensive strategic approach and development plan.
Regulatory
Ensure flawless interactions with regulatory agencies—from initial strategy, to submissions and meetings—informed by frequent interactions and up-to-date information.
Clinical & PK
Move your product efficiently and successfully through the clinic using a customized clinical design solution with an eye towards differentiated product labeling.
CMC Services
Avoid unnecessary delays and costs by integrating CMC components early in the development program, including strategic insights and management on vendors, processes, and quality controls.
Nonclinical
Reduce short- and long-term costs through a robust nonclinical program with support in methodology and strategy, study design, development, and accountability for program execution.
Commercial
Maximize the potential of your program throughout development and the commercial lifecycle with strategic insights that position your product for success.
Global Experts in the Path to Approval
We have experience in accelerated approval pathways, rare and specialty patient populations, and innovative science for both novel and 505(b)(2) products, including rare disease and orphan drugs, oncology, neuroscience, pediatrics, and MedTech.
