Amarex Successfully Supports a 510(k) Approval in a Gastroenterology/Urology Indication
Germantown, MD, USA (December 21, 2017) – Amarex is pleased to announce that one of its clients has received a 510(k) approval from the U.S. FDA on a medical device for use in a Gastroenterology/Urology indication. Amarex supported the regulatory efforts of this submission, along with providing full trial services for a companion study.
Dr. Kazem Kazempour, President and CEO of Amarex, said, “It is always a great pleasure to help a client obtain approval from the FDA for their product. We enjoyed working with this client through the development, submission, and approval process of this particular 510(k). We hope its medical benefits will provide relief to the patients that will use it.”
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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