Amarex Reaches Regulatory First
Germantown, MD, USA (January 24, 2017) – Amarex Clinical Research reached several regulatory firsts in late 2016. Amarex conducted a pre-IND meeting on behalf of our client. This meeting with the FDA did not last very long; the meeting lasted approximately 15 minutes, with 5 of those minutes used for participant introductions. Amarex’s CEO and President, Dr. Kazem Kazempour commented: “We did our homework, the FDA reviewers did their homework and there was a consensus with the IND strategy that we provided, that there was no need for further discussion. What a great job to our regulatory team.” The indication for this product that is being developed is Cardiovascular.
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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