Friday, August 10, 2012

"Big Box" Regulatory Affairs Consulting Groups

Credible Medical Products Regulatory Affairs and Quality Systems consulting groups are facing the influx of what I call “Big Box” medical consulting groups.  These groups advertise as experienced medical products consultants with group rate discounts and very low billing rates.  Initially these rates are attractive to customers who often times do not know to ask the questions to verify credentials.  By the time the customers realize they are receiving sub par and inaccurate advice as well as poor quality work it is often times to late.  These customers have already spent the money with low cost consultants and then find themselves with FDA problems.

Recently I reviewed one of these low cost consulting firms advertising for medical device consulting candidates.  The ad read “should have basic understanding of FDA regulations.”  When a company is hiring a consultant it is hiring that firm for its expertise.  This is not a “learn as you go assignment.”  The medical products consultant needs to be extremely knowledgeable on every facet of the FDA regulations not to only “have a basic knowledge.”  It is a regulatory consultant’s job to provide highly credible advice and superior work to make the customer’s job easier. 

My advice is Beware of these Big Box low cost consulting firms.”  I have seen where these consulting groups are only interested in a quick turnaround by supplying their customers with unqualified bodies at the expense of their customers.


  1. hello..
    Raymond Ursick sir..

    your advice help for us.

    Medical Affairs

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