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Featured Case Studies

Insight-driven and inventively bold, we excel in building strategies and developing highly customized programs. Our experience—from custom-designed clinical research studies to FDA registration and approval to commercialization—allows us to establish the best path to optimal outcomes.

Multidisciplinary Team Advances Immuno-Oncology Development
Date: July 24, 2020 Author: Ruth Stevens, PhD, MBA Project Lead: Stacey Ayres, PhD In...

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Combination Product Expertise and Target Market Knowledge Create Commercial Success

By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration.

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Real World Evidence Saves Project

When a biotech company could not afford the time and expense to conduct intended studies, we stepped in and quickly and creatively turned things around with the FDA.

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Rapid Nonclinical Planning and Coordination Keep Post-Marketing Requirements on Track

After a biotech company received paper NDA approval for their drug, Camargo contributed to successful commercialization, planning and executing Phase 4 post-marketing requirements with a short timeline.

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Strategic Submission Preparation Redefines Product Value

With strategic submission support, a biotech company gained approval for an improved delivery technology of an already-approved drug, setting the potential to become a new “gold standard” treatment in oncology.

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A Vitamin Approved as a Drug(!): Forget what you think you know to be true

Dogma says that a compound used for a nutrition, such as a vitamin, cannot be…

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Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known Already-Approved Drug?

Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known…

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Unforced Errors: FDA Refusal to File or Receive Letters

UNFORCED ERRORS: FDA Refusal to File or Receive Letters Few things can be more damaging…

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A New Indication for an Old Drug. What Could Go Wrong?

  A New Indication for an Old Drug. What Could Go Wrong? Desmopressin (DDAVP®; Ferring…

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Don’t Let Pre-Approval Inspections and the Drug Approval Process Stall Your Application

On May 27th, 2016, AstraZeneca announced they received a Complete Response Letter (CRL) from the…

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