Pharma Compliance Partners, LLC.
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
Contact Information
Email :
jjessen@phrmacompliance.com
Address :
USA
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