Walker Downey & Associates, Inc.

About Us

Walker Downey & Associates, formed in 2002 and led by Dr. Daniel McLain, current convener of ISO 10993-11 (Biological Evaluation of Medical Devices: Systemic Toxicity Evaluation) and Diplomate and Fellow of the American College of Forensic Examiners (Toxicology) and the American College of Nutrition, offer our invaluable industry and management experience in toxicology, pathology and histology, traditional and contemporary statistics, regulatory affairs, quality assurance, formulations and development, project management, and plasmid vector design to our clients navigating product safety and development approval processes.

Our customers range from venture capital-funded incubator companies to large pharma.

With over 25-years experience and a team of experienced associates, we offer solutions for:

• preclinical development program assessment
• comprehensive preclinical study development planning
• design and assemblage protocol assistance for preclinical studies
• placement and monitoring of studies at qualified CRO's
• preclinical study reports and associated regulatory documents
• risk assessments and expert opinions
• pre-510(k) and pre-BLA preparation for scheduled FDA meetings
• statistical, pathology and quality assurance services
• product formulation and development consulting

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.

Registered with Dun & Bradstreet

Biolife LLC (October 24, 2007) – Letter to the Project Team 

One of the major objectives we set out to accomplish this year was to obtain FDA approval to our first 510(k) submission. Today, we received from the FDA their signed approval to our 510(k), the primary implication of which is to acknowledge that our device components, which are quite new for medical applications, are considered safe and effective. As important, this initial 510(k) now provides a platform from which we can rapidly expand our product uses through new 510(k) applications. While this was simply an outstanding achievement on the part of everyone involved in preparing the submission, the contributions from our consulting toxicologist Dan McLain (www.walkerdowney.com) were indispensable.   Congratulations on a significant accomplishment that was done extremely well, and as soon as the rest of the team gets back to town... we will celebrate!!! Thank you for all your help and effort. 

Douglas R. Goodman

President & CEO, Biolife LLC

Florida Company of the Year -- Governor's Award