Electronic Submissions to the U.S. FDA – The Time Has Arrived!

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As of May 2018 the U.S. FDA requires all submissions related to regulated medical products to be made electronically through the FDA’s Electronic Submissions Gateway (ESG).

Primary Endpoint Successfully Achieved in a Phase 2b/3 Study for Treatment of HIV-1 Subjects

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Amarex Clinical Research helped a client successfully meet their primary endpoint in a Phase 2b/3 clinical trial of treatment-experienced HIV-1 patients.

Grand Opening Celebration of Amarex Taiwan, LLC

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Global Biotechnology Monthly recently interviewed Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, about the US FDA’s continued support for the development and marketing of digital health application products.

Collaboration Between Hanbat National University, Republic of Korea and Amarex Clinical Research

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On September 8, 2018, Amarex’s President & CEO, Dr. Kazem Kazempour, keynoted at the Trans 2018 digital health conference in Taipei, Taiwan.

Amarex Clinical Research Successfully Supports a 510(k) Approval in a Gastroenterology / Urology Indication

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Amarex Clinical Research 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. 

Amarex Clinical Research passes GCP Audit conducted by the FDA

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Amarex recently submitted an initial Pediatric Study Plan (iPSP) waiver request to the US FDA for a client’s product that is fast approaching the submission of an NDA. Amarex’s request for waiver was approved by the US FDA.

Amarex Clinical Research is Featured in a Montgomery College Economic Impact Video

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Amarex is pleased to have been asked to be featured in Montgomery College’s - Economic Impact Video. This is an effort to provide more insight to the college and businesses of Montgomery County in Maryland.

Amarex Clinical Research to Attend BIO Europe in Berlin

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Amarex will be attending the BIO Europe conference in Berlin over November 6-8.  In order to further expand both its clinical trial services in Europe, and its customer base in Europe, Amarex will be attending this conference for the first time.