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| Pharma Compliance Partners, LLC. |
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| Collaborating with pharmaceutical companies and clinical service providers in the areas of quality assurance compliance, project management, clinical research and device monitoring, regulatory affairs (submissions, review, and strategy) and operations. • FDA GCP • ICH GCP • EU Directive • GLP • GMP • 21 CFR Part 820 • 21 CFR Part 11 Quality Services Include: • Vendor audits (GMP, GLP, GCP) • Investigational Site Audits • Bioanalytical Laboratory Audits • Clinical Study Report Audits/Reviews • Part 11 System Audits • General System/Internal Audits • Pre-inspection Preparation • Process Implementation • Quality and Clinical Research Training • Project Management • Clinical Monitoring - Drug & Device • Technical Writing • Medical Writing • Standard Operating Procedures • Clinical Financial Analysis • Regulatory Affairs JoAnn Jessen President, Principal Consultant Suellen Bigaj Vice President, Principal Consultant |
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| USA |
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