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The FDA regulates the food we eat, medical products, blood products, lasers and lastly tobacco, all in the name of protecting the pubic health.  Congress routinely expands the scope of the FDA ‘s regulation and, therefore, FDA continuously implements new and more demanding regulatory controls.   How the FDA enforces its legal requirements and the procedures for doing so can be confusing and costly if you “don’t get it.”  The FDA is not known for great mercy when it comes to enforcing your errors or failures.   

Regardless of the type of products you put into commerce, when it comes to the FDA, you cannot afford to wing it, deny it or avoid it.  The FDA’s requirements are part of your commercial life.  Knowing how to meet the FDA’s requirements in a practical way is critical for your business.  How the FDA operates; how it thinks and predicting its next move requires expert knowledge.  Encore Insight LLC offers 32 years of experience from an ex-FDA senior official and offers the ability to negotiate through the maze of the FDA’s internal operations.

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Quarterly Blog: Cap's Twist on the FDA


Contact Encore Insight

Encore Insight LLC
Casper E. Uldriks

1678 West Harbour Towne Circle
Muskegon, MI 49441
casper.uldriks@gmail.com
Tel: (202) 664-2077
Fax: (202) 733-1674
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