Regulatory Strategy & Submissions
Strategy, documentation, and submissions for market access
Helping to Streamline the Regulatory Process
Through regulatory planning, documentation development, data compilation, and submission preparation, MRIGlobal provides guidance and submission support that is aligned with FDA and other global regulatory requirements. Our expertise in navigating the complex regulatory process supports compliance and helps demonstrate the requirements of safety, effectiveness, and clinical utility by guiding our customers at every step toward market access.
Expertise in Navigating the Various IVD Regulatory Pathways
Regulatory Risk Assessment and Mitigation
Identify potential regulatory challenges early on and develop strategies to address them.
Regulatory Strategy Development
Develop regulatory strategies and submission plans to support IVD clearance or approval.
Q-Submission Preparation and Support
Prepare Q-submissions or work with client to create key questions to gain meaningful feedback from the FDA.
Clinical Strategy Planning and Execution
Aggregate clinical and analytical data to demonstrate safety and effectiveness.
Regulatory Submission Support
Compile and complete IVD submissions.
Post-Market Support
Support execution of studies required by FDA post-market or to meet reporting requirements or claim expansion.
Latest from the blog
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MRIGlobal Helps Accelerate Approval of Hep C Diagnostic
The World Health Organization (WHO) estimates that 50 million people globally have a chronic hepatitis C virus (HCV) infection. HCV is a bloodborne virus that affects the liver and can lead to lifelong illness including liver cirrhosis and cancer, which can be life-threatening. It is also estimated that in 2022, approximately 242,000 people died due […]
Assay & Method Development Regulatory Strategy & Submissions Verification & Validation -
Point-of-Need Diagnostics
Have you ever swabbed inside your nose and used that sample to help diagnose if you have the flu or COVID-19? Or maybe you peed on a pregnancy test. The technology that makes those and other diagnostic tests like them possible is rooted in chemistry and enables people to manage their health from the privacy […]
Assay & Method Development Biological Threats Clinical Study Strategy & Execution -
Six Stages to Developing a Novel Infectious Disease Assay
Respiratory illnesses are generally characterized by a fever, a cough, and a sore throat. These kinds of infections are common during fall and winter and can occur in either the upper or lower respiratory tract. As the winter season gives way to spring, you may be reflecting on your own recent bouts of illness. Within, […]
Assay & Method Development Biological Threats Clinical Study Strategy & Execution
