FDA Consulting

FDA consultants at MRIGlobal are set apart by their ability to expertly gauge a project’s unique parameters and build a custom plan. Depending on the client’s needs and experience, portfolio managers can execute a detailed plan and make recommendations along the way to further optimize the portfolio and better ensure FDA approval. Although we are a non-profit, our staff have commercial experience that gives them an in-depth understanding of aligning company goals with a schedule and a budget.

Our ability to go above and beyond in this way is what truly sets us apart from other contract research organizations (CROs). Our ultimate responsibility is finding the best path through FDA clearance.

Quality FDA consulting for medical device development means thoroughness and innovation. We are able to bring a new approach from a regulatory standpoint because we have experience knowing the level of testing required or the approach that might be more successful with the FDA. Many projects are owned by business-minded people with great ideas, but they may not have experience in navigating the FDA path—that’s where MRIGlobal comes in. All of our FDA consultants’ efforts, from development to submission, are measured against a rigorous quality assurance program.

There are several reasons companies seek diagnostic development assistance. Even huge conglomerates with a very mature, robust system may lack the bandwidth or resources to complete the process because they have more products they’re attempting to get to market than they have the resources to execute all at once. 

An FDA consultant from MRIGlobal can provide both recommendations and tangible resources to help accelerate the development, viability testing, and FDA clearance process for your device. Our laboratories, expertise, training, and clinical resources can reshape your diagnostic development plan.