MAA Filed in Five EU Member States
Germantown, MD, USA (September 25, 2017) – Amarex Clinical Research prepared and submitted a Marketing Authorization Application (MAA) to five EU countries, through the Common European Submission Portal for a drug intended to treat an important urology indication in men.
The product, which has been in development for several years, recently completed two large Phase III studies that are being used as pivotal studies to support the drug’s approval. In addition to the application writing, Amarex handled the trial data analysis and prepared the integrated summaries of safety and efficacy used in the MAA. The regulatory review is underway and a decision on the MAA is expected to be on target as we do not anticipant any delays. Amarex also is preparing to file the NDA application to the U.S. FDA. Both applications are in eCTD format.
Amarex’s CEO, Dr. Kazem Kazempour said: “Amarex Clinical Research is very pleased to have helped our client reach this important milestone. It is a testament to our team’s ability to provide sound regulatory advice, and our growing work in the EU.”
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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