24 January 2017
Amarex Clinical Research reached several regulatory firsts in 2016
Germantown, MD, USA - Amarex Clinical Research reached several regulatory first in late 2016. Amarex conducted a pre-IND meeting on behalf of our client. This meeting with the FDA did not last very long; the meeting lasted approximately 15 minutes, with 5 of those minutes used for participant introductions.
Amarex's CEO and President, Dr. Kazem Kazempour commented: “We did our homework, the FDA reviewers did their homework and there was a consensus with the IND strategy that we provided, that there was no need for further discussion. What a great job to our regulatory team.” The indication for this product that is being developed is Cardiovascular.
About Amarex Clinical Research, LLC
Amarex is a global full service Contract Research Organization (CRO) that provides complete regulatory and clinical development services to take client's products from laboratory proof of concept to achieving FDA approval of new or re-purposed medical products. Amarex creates regulatory approval plans for their clients and executes those plans through clinical research up to and including NDA, BLA, PMA, or 510(k) applications. Amarex works with all types of medical products in all therapeutic indications. The leadership team's experience spans 30+ years of clinical research in Phase 1-4 trials, for over 300 projects, in more than 60 countries.
20201 Century Blvd, 4th Floor
Germantown, MD 20874