GxP Quality Systems

Need assistance meeting commitments to audit suppliers or business partners against FDA, European, or other global device, biopharma, or diagnostic regulations? We can help maintain a clinical or commercial supply chain compliant with GCP, GMP, and GLP quality systems, third party vendor management plans, and risk management programs. We also routinely help laboratories that perform routine and non-routine testing of clinical samples adhere to CAP and CLIA requirements. Pearl Pathways will first conduct a gap analysis to find any existing absences before a regulatory body does. Further, we understand the importance of continuous compliance monitoring to ensure that your efforts and those of your supply chain partners are both current and effective.

Areas of expertise include drugs, biologics, devices, diagnostics, nutraceuticals, dietary supplements, generics, food, combination products, compounding pharmacies, and radiopharmaceuticals:

Clinical—21 CFR Parts 50, 54, 56, 312, 314, 361

Manufacturing—21 CFR Parts 210, 211, 111, 820, 600, 601, 610

Non-Clinical—21 CFR Part 58

Electronic Records/Signatures—21 CFR Part 11

ISO—13485, 14155, 14971, 22716, 9000s

ICH—Q7A, E6, E2A

Compounding Pharmacy—USP 797

European Directives—2001/20/EC, 2005/28/EC