New Drug Application to the U.S. FDA for Parkinson’s Treatment
Germantown, MD, USA (November 19, 2020) – The regulatory department at Amarex Clinical Research, LLC, an NSF International company, recently submitted a new drug application (NDA) on behalf of its client. The Amarex team also wrote a substantial portion of the NDA and did the publishing.
The new drug is a combination of two approved drugs and will hopefully be a valuable addition to currently available treatments for Parkinson’s.
President & CEO of Amarex, Dr. Kazem Kazempour, “Our Regulatory team worked hard on this NDA. We are proud to be a part of this project and to help advance a new drug for such a serious disease towards marketing approval”.
Amarex’s regulatory experts are available to outline product development strategies that are efficient and cost effective, to manage FDA meetings, and to prepare and submit regulatory applications in North America, Europe, and Asia. Amarex has also established an eCTD submission system in order to comply with new FDA eSubmission requirements.
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit www.amarexus.com.
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