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- Amarex Accelerated COVID-19 Product Authorization/Approval Services
Amarex Accelerated COVID-19 Product Authorization/Approval Services
Germantown, MD, USA (May 19, 2020) – Amarex Clinical Research, LLC, an NSF International company, is an expert at streamlining regulatory and clinical trial testing services for product development and FDA approval.
We are applying additional resources to rush timelines for all COVID-19 product projects. Some recent examples:
- <1 week to achieve FDA approval for emergency IND of antibody product to treat severely ill COVID-19 patients; parallel management of treatment clinic setup; 50+ patients treated since March approval
- 1 month to achieve Phase 2 clinical trial approval for repurposed antibody treatment for mild-to-moderate COVID-19 patients
- 1 month to achieve Phase 2b/3 clinical trial approval for repurposed antibody treatment for severely ill COVID-19 patients
- <2 months for parallel submissions: 4 pre-IND and IND applications, 2 IDE supplements, 3 EUA applications and multiple notification of Emergency Uses to US FDA as well as 2 CTAs to the UK MHRA for COVID-19 products
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.
Patrick J. Burke
20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
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