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FDA GCP Audit of Amarex
Germantown, MD, USA (January 15, 2015) – This past week, the U.S. FDA conducted a GCP audit of Amarex headquarters, and the result was 'no findings' and no '483s'. The FDA auditor complimented Amarex's SOPs, documentation, and the helpfulness and thoroughness of the Amarex employees that assisted with the audit.
The FDA performs audits as part of their medical product approval process. This audit was due diligence for a pending FDA Marketing Approval for the product of an Amarex client. The audit involved an overall systems audit of Amarex and examined Amarex's SOPs, documentation practices, personnel training, and facility design.
Dr. Mukesh Kumar, VP of Amarex Regulatory Affairs, said "this audit demonstrates the high quality performance applied to Amarex managed clinical trials. This is our second 'clean bill of health' FDA audit in the past five years."
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
Patrick J. Burke
20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
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