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:
21 CFR Parts 50, 54, 56, 312, 314, 361, 14155
21 CFR Parts 210, 211, 111, 820, 600, 601, 610
21 CFR Part 58
21 CFR Part 11
13485, 14155, 9000s
Q7A, E6, E2A
21 CFR Part 202
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