Provectus Biopharmaceuticals, a Knoxville, Tenn.-based development-stage oncology and dermatology biopharmaceutical company, has retained INC Research, a Raleigh, N.C.-based global CRO, 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. 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.