Floridians & Florida Constitution – Knowledge is Power !

 Voting is a fundamental right of any citizen that enables them to choose the leaders of tomorrow. In many countries, the minimum age for voting is 18 years. Voting not only enables the citizens to vote for political parties, but it also helps them to realize the...

One Team , One Goal – Your Business Transformation !

  If you’re reading this post, then you’re probably considering utilizing our team expertise at your company. As President and CEO of Lean Enterprise Consulting Inc. (LEC), I’m very pleased to hear that! When you join forces with the great team of...
Elite “coterie” of Professionals !

Elite “coterie” of Professionals !

Do you classify yourself as an elite breed of professional that looks for and hire for competencies, knowledge, people skills, and ROI on your consultant’s services above all other considerations? If you answered yes, then you are the rare and unique category of...
Lawsuits,Federal Budget Cuts and FDA – The Prophecy !

Lawsuits,Federal Budget Cuts and FDA – The Prophecy !

In a previous post, I shared with all of you my opinion about Mr. Trump’s “nefarious” decision to reduce the FDA budget and the rise of a “Regulatory Anarchy”. Today, in the newspaper, to validate my prophecy, I found this...

Over-spending $ Responding to a FDA 483 ? No need

Is your company over-spending in regulatory support? Dealing with a 483? FDA Warning Letters requires immediate and expert attention …they mean that the Agency has found that one or more of your practices, processes, or products are in violation of FDA...

LEC PRAESENTI – FDA medical device or device-led combination product submissions

 FDA Issues Draft Guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Today, the U.S. Food and Drug Administration issued the draft guidance document, “Requests for Feedback and Meetings for Medical Device...