Amarex Taiwan is an affiliate of Amarex Clinical Research,
a full-service, international CRO with extensive experience successfully performing clinical studies across all phases of research and
discovery, development, validation and approval.
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.
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..
Recommended by the people who matter most: our clients.
Chief Medical Officer
A Maryland Biotech Company
We have worked with Amarex on numerous projects and they consistently deliver high quality reliable service by leveraging a broad array of clinical and regulatory expertise. What sets them apart from other CROs is a creative entrepreneurial approach to drug development. They go beyond the technical aspects of clinical trial development and work with the sponsor to drive value and increase chances for success.
Chief Technical Officer
A Canadian-based Infectious Diseases Organization
[Thank you to the team at Amarex] for the statistical support which proved to be invaluable and completely accurate in the final review by FDA. The cornerstone of this milestone achievement was the data from the clinical study, including the limit of detection study, and we came through [all FDA reviews with solid outcomes throughout]. From all of us here, a sincere thank you and well done to all at Amarex who worked on this project. We look forward to working with you again as we apply the successful platform to other diagnostic device developments in the future.