INC Research Signs Agreement to Perform FDA Due Diligence Audit of Regulatory Documents
Provectus Biopharmaceuticals, Inc. has announced that it has retained INC Research, a leading, global Phase I to IV contract research organization, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10.
The audit will be conducted in two phases, both of which are expected to be completed by early November 2014. In the first phase, INC Research Quality and Compliance Consulting will undertake a regulatory document inventory and evaluation of the contents of Provectus' information management system (the Smart Room).
The results of this phase will generate a document request list, and the second phase of the audit 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.
The audit will not touch on assessing information and relevant documents specific to marketing applications, marketing and promotion activities, nor will it address nonclinical and clinical data supporting final reports.
Dr. Craig Dees, PhD, CEO 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 3 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."