About Us

Pharma Compliance Partners, LLC specializes in 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

Our Services

  • 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