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The Prescription Drug Marketing Act was enacted in 1987 to ensure drug products are safe and effective for consumer use. The act increased drug distribution safeguards to prevent the distribution or retail of counterfeit, adulterated, misbranded, subpotent or expired drugs.

Arbour Group audits will evaluate processes, systems and operational controls based on established client policies and procedures, as well as applicable FDA regulations and guidelines in concert with industry best practices to ensure PDMA compliance.

PDMA risk areas in the scope of an audit may include:

  • Sampling shipping discrepancies
  • Regulatory reporting
  • Reconciliation
  • Returns
  • Signatures
  • 21 CFR Part 11
  • System Validation

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.

 

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