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.

3 comments:

  1. hello..
    Raymond Ursick sir..

    your advice help for us.

    Medical Affairs

    ReplyDelete
  2. Worksure Medical communication service help customers to manage their manage clinical data, drug promotion, risk management strategy successfully and effectively

    ReplyDelete
  3. Hi,I highly appreciate your writing.I'd like to share few point with you.EAS offers a standout amongst the most encountered aggregations of masters accessible on FDA regulatory consistence issues. We offer a group of previous elevated amount FDA authorities and industry experts who will impart their smoothness to our customers. Our consultants have a normal of in excess of 25 years regulatory encounter, and incorporate probably the most well-known and very regarded names in the business. As new guidelines and regulations mushroom, EAS stays informed concerning the changing regulatory scene, permitting us to convey up-to-the-moment arrangement guidance to our customers. Our masters have the learning, capabilities, and experience important to illustrate and elucidate the issues to our customers and the courts, while making believability and convincingness as witnesses.Thanks you so much!!!!
    >>>>>>>>>>>>>>>>>>>>>
    majakel

    ReplyDelete