Amarex Site Passes Surprise FDA Audit
Germantown, MD, USA (December 17, 2014) – A site taking part in an Amarex Clinical Research-supervised Surgical Wound Healing and Cosmesis study recently passed a surprise FDA audit with no findings. The audit was planned for 4 days but finished earlier than expected, and no FDA Warning Letter (Form 483) was issued.
Amarex CEO Dr. Kazem Kazempour said "this successful audit highlights the dedication and work ethic that Amarex's professionals are known for. The result of this audit speaks of Amarex's high standards of quality."
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.
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