COVID-19 Drug, Diagnostic and PPE Product Emergency Use Authorization (EUA) Services
Germantown, MD, USA (April 16, 2020) – Amarex Clinical Research, an NSF International company located within the Greater Washington DC Area, is helping organizations prepare and submit Emergency Use Authorizations (EUAs) and expanded access, also called “compassionate use”, requests for U.S. FDA approval of drugs, medical devices and IVD kits to treat and diagnose the coronavirus disease 2019 (COVID-19).
For treatment therapies, these include products that 1) attack the SARS-CoV-2 virus, 2) reduce symptom complications caused by SARS-CoV-2, such as cytokine storm syndrome, lymphocytopenia and acute respiratory distress syndrome, and 3) promote immunity against the virus, such as with passive antibody therapy. This also includes products that are approved for other disease indications and products not yet approved but currently under Phase 2/3 clinical investigation.
For diagnostic products both virus detection and viral antibody detection, through serological testing, are important.
Amarex can also assist clients with obtaining rapid FDA approval for masks and other personal protective equipment (PPE) intended for use by healthcare professionals.
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, 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.
Book a meeting or send us a message to talk to one of our experts.