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Let a former FDA medical officer help you
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Prepare for FDA
inspection with "Mock FDA Audit"
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Train your staff
in GCP's, good clinical practices
At your site at your convenience.
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Compliance issues
Prevent 483 or respond to 483
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Negotiate with
FDA at meetings
Prepare for Pre-IND, pre-IDE or 483 responses
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Get your first
patient into your clinical trial
"The
FDA is Coming to Audit Your Clinical Studies: How You Should Prepare"
Click here
Perkins
and Perkins, Inc, PPI was established in 1984 by a former FDA medical
officer.
PPI has successfully worked with pharmaceutical and medical device
companies. We have saved sites from getting 483s, gotten non-approval
products to market, helped get first patient into clinical trials,
negotiated labeling issues and helped companies resolve 510k verse PMA
issues. PPI has saved companies time and money with regulatory strategy.
By asking companies the right questions, we have saved time and money in
getting products to market. |