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Walker Downey & Associates, Inc . led by Dr. Daniel McLain, current US AAMI TC194/WG7 Chair and convener of ISO 10993-11 (Biological Evaluation of Medical Devices: Systemic Toxicity Evaluation), offer our extensive industry experience in toxicology, traditional and contemporary statistics, regulatory affairs and quality assurance to our clients navigating the product safety and development approval process. Our customers range from venture capital-funded incubator companies to large pharma.

Our experienced and dedicated associates offer solutions for:
  •   preclinical development program assessment
  •   preclinical study development planning
  •   placement and monitoring of CRO studies
  •   troubleshooting unexpected events
  •   risk assessments and expert opinions
  •   FDA meeting support and responses
  •   statistical design and review
  •   RA/QA services