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The McKibben Group LLC

Providing Expert Services When Leadership & Teamwork Matter

With over a decade of experience in FDA-specific projects in government and industry, Dr. McKibben is the atypical clinical regulatory expert who can both lead projects and work productively on teams alongside CMC, non-clinical and other regulatory process professionals and science experts to analyze and report gaps or weaknesses in FDA regulatory packages or in the clinical strategies of biotech and pharmaceutical companies. Dr. McKibben is also committed to providing expertise in health policy, public health science, and pediatrics to non-profits to improve delivery or administration of community pediatric or clinical preventive services.

Gap Analysis

  • Determining whether the clinical package or evidence is adequate to meet FDA requirements; Recommending a path forward; Guidance in preparing for or presenting within FDA meetings

Due Diligence

  • Assisting potential buyers of FDA regulated products to make sound decisions about the clinical evidence.

Expert Witness

  • Assessing the strengths and weaknesses of evidence for the clinical effectiveness and safety of FDA-regulated products‚Äč


  • Supporting non-profit organizations to bring good ideas into practice by reviewing, authoring, or joining grant-writing teams seeking public or private grant support

Pediatric Advocacy

  • Reviewing, writing, or providing testimony for pediatric and child health-professional groups to communicate more effectively to policymakers

Clinical Trials

  • Supporting research funders to provide guidance on reporting of safety events in clinical trials
  • Evaluating clinical evidence from observational studies and clinical trials
  • Evaluating clinical protocols for clinical preventive services or pediatric therapeutics

What our clients & partners are saying

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