Amarex Client Receives U.S. FDA Marketing Approval for Hemoconcentrators 

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Germantown, MD, USA (February 23, 2024) – Amarex Clinical Research, LLC, an NSF company is pleased to announce its client Tecnoideal America, Inc. received U.S. FDA 510(k) clearance for hemoconcentrators used in adult patients during or after cardiopulmonary bypass surgery to remove excess fluids from the blood and restore physiological blood conditions. This product successfully completed performance and substantial equivalence testing, and the data proved the device to be substantially equivalent to the predicate device. 

Amarex Celebrates Its 25th Anniversary!

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Germantown, MD, USA (February 02, 2024) – Amarex Clinical Research, LLC, an NSF company, announces December 2023 marked its 25th year advancing patient access to safe and effective clinical products through delivery of outstanding regulatory and clinical trial services to Sponsors within the life sciences industry.

Amarex Taiwan Chief Operating Officer, Dr. Chia-Hua Maggie Ho, Featured in 2021 End-of-year Global Bio Investment Article: Bringing U.S. FDA Review Criteria to the Taiwanese Biotech Industry

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Many non-COVID-19 global clinical trials are delayed or terminated early due to the COVID-19 pandemic. The clinical trials carried out by Amarex were not forced to be suspended or terminated during the pandemic. Amarex set up the monitoring plan and audit system remotely and that not only overcomes the difficulty of on-site monitoring but also ensures the quality of clinical trials and the safety and rights of subjects.

Amarex Taiwan Exhibiting at BIO Asia-Taiwan 2021 | Nov. 4-7 | Taipei, Taiwan

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Taipei, Taiwan (November 02, 2021) – We are pleased to announce that Amarex Taiwan, LLC is exhibiting at BIO Asia-Taiwan 2021, held November 4-7 at the Taipei Nangang Exhibition Center in Taiwan.

Amarex Passes Taiwan FDA GTP Audit: Result is a Resounding No Findings

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Taipei, Taiwan (September 16, 2021) – Amarex Taiwan, LLC announces a no findings result of a Taiwan Food and Drug Administration (TFDA) audit of its office last month.

Amarex Featured in 15-year Anniversary Issue of the NSF International Journal

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The just released Issue 48 of NSF International’s Health Science Journal features contributions by Amarex Clinical Research, LLC. This journal is available at https://www.nsf.org/periodicals/health-sciences-journal/issue-48.