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
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
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
Amarex Taiwan Exhibiting at BIO Asia-Taiwan 2021 | Nov. 4-7 | Taipei, Taiwan
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
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
Amarex Featured in 15-year Anniversary Issue of the NSF International Journal
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
Amarex Job Openings at the BioCapital Life Sciences Career Fair | Feb. 18, 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
Enrichment Strategies to Increase the Power/Reduce the Sample Size in Clinical Trials
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.
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.