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Electronic Submissions to the U.S. FDA – The Time Has Arrived!

Germantown, MD, USA – As of May 2018 the U.S. FDA requires all submissions related to regulated medical products to be made electronically through the FDA’s Electronic Submissions Gateway (ESG). This includes submissions such as Investigational New Drug (IND) applications, amendments, annual safety reports, New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), etc. The submissions are to follow the International Council for Harmonization guidelines for the electronic Common Technical Document (eCTD) formatting and hyperlinking.

Amarex’s Regulatory department has been making eSubmissions for over a year as clients prepared for this requirement. Amarex has a very efficient process to make electronic submissions, and is ready to be of service to you in setting up your ESG account and managing your future submissions.

Amarex continues to offer eCopy submission services for Investigational Device Exemptions (IDE), Premarket Applications (PMAs), and 510(k) applications.

About Amarex Clinical Research

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 Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.

Patrick J. Burke
Business Development

20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000

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