Amarex’s Regulatory Affairs Department is pleased to announce a record year for new regulatory submissions to the US FDA. In 2019, Amarex submitted 12 Investigational New Drug (IND) applications, six 510(k) application, portions of a rolling Biologics License Application (BLA), one Drug Master File (DMF) application and one New Drug Application (NDA). Amarex also filed over 135 amendments to existing regulatory submissions and two of our clients had products approved in 2019.
17 February 2022
Taipei, Taiwan (February 17) - 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.
02 November 2021
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.
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.
24 February 2021
The just released Issue 48 of NSF International’s Health Science Journal features contributions by Amarex. The journal is available at https://www.nsf.org/periodicals/health-sciences-journal/issue-48.
15 February 2021
We are featuring current job openings at the MD Tech Council BioCapital Life Sciences Career Fair, Thursday, February 18th. This virtual event is free and open to all students and job seekers interested in career opportunities in the life sciences industry. Register for this virtual event, visit our booth, and speak to an Amarex representative about expanding your career: mdls.vfairs.com.
25 January 2021
On January 07, Dr. Kazem Kazempour, President & CEO, conducted the webinar Enrichment Strategies to Increase the Power/Reduce the Sample Size in Clinical Trials. View the full webinar recording on our YouTube channel.
18 January 2021
Our client’s Phase III clinical trial for patients with severe-to-critical COVID-19 symptoms reached full enrollment (390 patients) in mid-December. Data analysis results are expected this quarter. The trial was conducted in the U.S., Canada, and U.K..