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
- 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.