2019 Regulatory Affairs Year in Review
Germantown, MD, USA (January 28, 2020) – 2019 was an exciting year of growth and discovery for Amarex Clinical Research, and we are excited to report the below noteworthy achievements.
Amarex’s Regulatory Affairs department offers a competitive regulatory strategy to clients and maintains successful interactions with the U.S. FDA and foreign regulatory bodies. In 2019, Amarex prepared and submitted 12 Investigational New Drug (IND) applications, six 510(k) applications, 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.
The U.S. FDA approved a new rapid in vitro diagnostic (IVD) kit, Vstrip, for detection of H. pylori infection. Amarex’s clinical team designed the trials and managed clinical performance of the studies in the U.S. and Taiwan for this product. In addition, Amarex’s biometrics and regulatory departments worked together on the data analysis and the preparation of the 510(k) application.
The U.S. FDA also approved a new prescription weight management aid to be used in conjunction with diet and exercise to treat overweight and obese adults (BMI 25-40 kg/m2). This product successfully completed five clinical studies at several sites across the United States, Canada and Europe, with research data demonstrating safety and efficacy as a weight management aid. Amarex’s biometrics department provided statistical analysis services, aiding in the development of this product.
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 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.amarexus.com.
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