Regulatory Submissions Anda, Regulatory Submissions Bla, Medical Device Consulting, Medical Device Regulatory Consultants, Pharmaceutical Regulatory Consulting, Quality System Development, Quality Regulatory Consulting, Quality Consulting Regulatory, Regulatory Consultants Pharmaceuticals, Regulatory Consultants Biotechnology, Fda 510(K)When We Can Help

Every member of our team has extensive industry experience.  Within the course of our collective careers, we have solved the same issues that now challenge you and your team.

We have a broad scope of expertise over a wide range of device, pharmaceutical, biotechnology and human tissue based product and manufacturing technologies. Click on “WHO WE ARE” to learn more.

Our client base extends from small start-up companies to large multi-national corporations, located around the world. We can assist in a wide range of situations, from developing/revising and deploying your quality system to designing, monitoring and auditing your clinical trials, to deploying and validating new computer technology, to developing and validating new manufacturing processes, equipment or facilities. 

Whether you need help preparing for and managing a difficult regulatory inspection or responding to a less than favorable inspection outcome, require outside resources to complete a regulatory submission for a new product, or have a quality problem that you just can’t seem to solve, we can help by adding our strengths to yours.  Click on “WHAT WE DO” to learn more.

We can arrange on-site or web-based live training for your team in a variety of topics to assure your expertise remains current.  Click “HOW TO CONTACT US”

Our Experience is What Makes the Difference.

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