FDA Regulatory Intelligence | E & E Medicals & Consulting

Call Us: (678) 385-6124 (Mon - Fri)

Mail us for help: info@eemedicals.com

Enquiry Form: Share Your Project

Call Us: (678) 385-6124 (Mon - Fri)

Mail us for help: info@eemedicals.com

Enquiry Form: Share Your Project

Best CE mark approval for medical devices consultants

The CE marking (known as CE mark) is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA).

Biologics License Application (BLA)

Pre-submission and strategic guidance in determining the best route for BLA submission to regulators..

Chemistry, Manufacturing, and Control

E&E Medicals, a leading player in centralized Chemistry, Manufacturing and Controls (CMC) lifecycle management for Regulatory submissions, offers services for CMC Regulatory affairs.

New Drug Application

Help before submitting to the US Food and Drug Administration, including putting together a briefing package and attending a meeting to discuss scientific issues.

US FDA 510(k) Consultants

We prepare and submit FDA medical device regulatory documents and class I, II and III medical devices for the U.S and international clients.

Unique Six Sigma Program

DMAIC model - Define, Measure, Analyze, Improve, and Control

Professional Quality & Regulatory Affairs

Professional Quality & Regulatory Affairs

Our experts solve critical and complex problems of our clients