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Provectus Retains INC Research for FDA Audit

Will undertake a regulatory document inventory and evaluation of Provectus’ information management system

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By: Kristin Brooks

Managing Editor, Contract Pharma

Provectus Biopharmaceuticals, Inc. has retained INC Research to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10. The audit, conducted in two phases, is expected to be complete early November 2014.
 
In the first phase, INC will undertake a regulatory document inventory and evaluation of the contents of Provectus’ information management system (the Smart Room). The results of which will generate a document request list, and the second phase will involve further evaluation of the requested documents. This will entail onsite verification of the regulatory documents and a final analysis of diligence issues identified in the audit.
 
Dr. Craig Dees, Ph.D., chief executive officer of Provectus, said, “Provectus is pleased to be working with INC Research Quality and Compliance Consulting in conducting this audit. By retaining their services, we are endeavoring to ensure that the upcoming Phase III trial for PV-10 as a treatment for melanoma as well as the future tests of both PV-10 for other indications and for PH-10 to treat dermatological diseases proceed with all possible speed. Making sure that all the paperwork is available and in good order will smooth out the process.”

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