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.
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.