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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 management experience in toxicology, pathology and histology, traditional and contemporary statistics, regulatory affairs, quality assurance, and project management to our clients navigating the product safety and development approval process. Our customers range from venture capital-funded incubator companies to large pharma.

    

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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
  •   pathology and histology
  •   RA/QA services
  •   project management
To find out how our years of experience and expertise in biological evaluation and testing, quality and regulatory affairs, risk management and safety, statistical analysis, and new product development can help your company, please contact us at info@walkerdowney.com.