GXP Quality Systems

Need assistance complying with FDA, European, or other global device or biopharma regulations? We help create efficient and compliant CGMP, GLP, and GCP quality systems, third party vendor management plans, and risk management programs.  We conduct a gap analysis as the first step so we find your gaps before the FDA does. Further, Pearl Pathways knows the importance of continuous compliance monitoring to ensure that your efforts are up to date and effective.

Areas of expertise across drugs, biologics, devices, diagnostics, nutraceuticals, dietary supplements, food, combo products, compounding pharmacies, and radio-pharma include:

Clinical:
21 CFR Parts 50, 54, 56, 312, 314, 361, 14155

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, 9000s

ICH:

Q7A, E6, E2A

Compounding Pharmacy:

USP 797

Drug Advertising:

21 CFR Part 202

European Directives:

2001/20/EC; 2005/28/EC;

Don’t see one you are looking for?  Just ask.