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Looking for FDA Assistance?
Let a former FDA medical officer help you
  • Prepare for FDA inspection with "Mock FDA Audit"

  • Train your staff in GCP's, good clinical practices
    at your site at your convenience.

  • Compliance issues
    prevent 483 or respond to 483

  • Negotiate with FDA at meetings
    prepare for Pre-IND, pre-IDE or 483 responses

  • Get your first patient into your clinical trial

"The FDA is Coming to Audit Your Clinical Studies: How You Should Prepare"

Perkins and Perkins, Inc, PPI was established in 1984 by a former FDA medical officer.
PPI successfully worked with pharmaceutical and medical device companies. We saved sites from getting 483s, propelled non-approval products to market, helped get first patient into clinical trials, negotiated labeling issues and helped companies resolve 510k verse PMA issues. By asking companies the right questions, PPI saved companies time and money with regulatory strategy.

 


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