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- Amarex Passes FDA Audit with High Compliments from FDA Auditor
Amarex Passes FDA Audit with High Compliments from FDA Auditor
Germantown, MD, USA (February 04, 2010) – Amarex Clinical Research was informed by the FDA that Amarex had been randomly selected for a GCP audit of her CRO services business, giving Amarex less than a week to prepare. "The result of the audit was a resounding 'A+ grade' for Amarex", according to Dr. Mukesh Kumar, Amarex's Senior Director of Regulatory Affairs. "The FDA auditor was very complimentary of Amarex's SOPs, documentation system and training program, calling them 'some of the best in the industry' based on her many years of auditing experience." Documentation from several randomly selected clinical trials conducted over the last 3 years was also audited and given a clean bill of health...No 483s...No minor observations and a recommendation of No Action Indicated (NAI).
Dr. Kumar added, "I was confident Amarex was in very good shape regarding GCP regulatory compliance, but it was especially gratifying to have no findings and to have the FDA auditor be so complimentary of Amarex."
The FDA's formal report will be processed and posted to the FDA website sometime this month.
Department of Health & Human Services
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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