Why ShoeBar Associates

• We have direct experience with the science, engineering, and operations in FDA-regulated companies – we understand your business.
  
  
• We stay informed on FDA and ISO expectations, and can guide your team to make sure those expectations
  are met.
  
  
• We can offer expanded resources through collaborations with other software-validation and medical device consulting firms.
  
  
• We’ve been closely involved with implementing electronic records and signatures to satisfy FDA regulations.
  
  
• We have designed and implemented software quality systems multiple times (SOPs and associated templates) - our outlines and templates will save you time.
  
  
• We adapt to our clients’ structure, document standards, and organization.
  
  
• We can either scope out and manage the entire project, or act as an extension of your quality team.
  
  
• Thoroughness and care are hallmarks of all our projects.
  
  
• Our approach to compliance is practical – not “how many documents can we generate,” but “what documentation do you really need?”
  
  
• We partner with our clients, to make sure they can continue their compliance work after we’ve left.