Investment by NSF International in Amarex
Germantown, MD, USA (October 09, 2019) – Amarex Clinical Research, LLC is pleased to announce that global public health organization NSF International has made majority investment in Amarex. The investment supports both Amarex’s mission of expediting patient access to safe and effective clinical products, and NSF International’s mission of protecting and improving human health, through expanded services to the medical device and pharma/biotech industries. Amarex will be a part of NSF International’s global health science consulting business, and will be referred to as Amarex Clinical Research, LLC, an NSF International company. Amarex founder Dr. Kazem Kazempour, will continue as President and CEO of Amarex under NSF International.
Amarex will gain access to NSF International’s expert network and international scope. As part of NSF International’s global network of locations, Amarex will continue to operate from its U.S. office near Washington, D.C. Amarex will also continue to operate its office in Taiwan and develop its presence in Europe.
“Amarex is excited to join the NSF International family. Amarex will be able to leverage NSF International’s global infrastructure to expand our contract research capabilities and better serve clients with the design and execution of clinical trials and navigating the FDA, TFDA and EMA regulatory approval process,” said Dr. Kazem Kazempour. “NSF International’s operational excellence will accelerate our expert team’s leap forward in the CRO market, and better help pharmaceutical, biotech and medical device/diagnostic companies to develop products and services that will protect and improve human health while minimizing inefficiencies to save time and reduce unnecessary costs.”
“NSF International plays an important role in the pharmaceutical and biotech industry as a champion of quality, scientific rigor and best practices aimed at protecting and improving human health. Together with Amarex, we are creating a single source for integrated, expert health science consulting services across the entire product lifecycle,” said NSF International President and CEO Kevan Lawlor. “Amarex brings clinical trial expertise to NSF International’s large base of training, quality and consulting clients, and Amarex’s CRO clients may now benefit from NSF International’s global reach and expertise in European Union Qualified Person and Medical Device Regulation training, chemistry manufacturing and controls support, and supplement testing inspection and certification.”
Since 1998, Amarex has been helping biotech, medical device and pharmaceutical companies conduct scientifically sound clinical trials and navigate complex regulatory environments in a wide range of therapeutic indications, including, but not limited to: oncology, central nervous system, wound healing, infectious disease, cardiovascular and urology.
As part of NSF International, Amarex will support companies with regulatory affairs, project/trial management, clinical operations, biostatistics, data management, pharmacovigilance, data monitoring committees, medical writing and consulting.
In 2019, NSF International is celebrating 75 years of protecting and improving human health. The global public health organization facilitates standards development, and tests and certifies products for the food, water, health sciences and consumer goods sectors to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
NSF’s health sciences services include training and education, consulting, regulatory guidance, corporate compliance and, separately, auditing, DNA testing, certification and R&D for the pharma biotech, medical device and dietary supplement industries throughout the product lifecycle. NSF facilitated the development of the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.
About Amarex Clinical Research, LLC
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive 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. Amarex provides high quality and cost efficient services. For more information, visit www.amarexcro.com.
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