Camargo specializes in complex drug development programs where no playbook exists, with integrated solutions spanning from product concept to commercial stages that enable sponsors to reach milestones with speed and capital efficiency.
About Camargo
Experts in the Path to Approval
We have experience in accelerated approval pathways, rare and specialty patient populations, and innovative science including orphan drugs, the 505(b)(2) pathway, oncology, neurology, pediatrics, combination products, and digital therapeutics.
Oncology Expertise
505(b)(2) Expertise
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 FDA 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.
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.
Clinical & PK
Move your product efficiently and successfully through the clinic using a customized clinical design solution with an eye towards differentiated product labeling.
