ARROWSMITH-LOWE CONSULTING, Inc.

Each consultant has 12 years' experience at the US Food and Drug Administration (FDA).  The combined experience encompasses pre-market and post market regulatory activities in the Centers for Drug Evaluation and Research, Biologics Evaluation and Research and Medical Devices and Radiological Health.

• Good Manufacturing Practices and Quality Systems Regulation audits for medical device manufacturing.
  

• Good Tissue Practices and Final Rule compliance audits for processors of human tissue.
  

• Development of Good Tissue Practices for human tissue banks. 
  

•           Pre-market clinical trial designs for INDs and IDEs.
  
  

• Preparation of FDA pre-market submissions for medical devices, biologicals, human cell, and tissue-derived products.
  

• Expert consultation concerning products regulated as pharmaceuticals, medical devices and biologicals, including human tissue.
  

•           Review and evaluation of post-market safety reporting practices.
  
  

•           Compliance with Medical Device Reporting regulations for 
             user facilities.
  
  

•           Clinical consultative services.