Don't be caught without a valid FDA Facility Renewal!

With a team of former FDA agency officials and regulatory experts, we provide insights and strategies to navigate the complex journey of FDA compliance such as facility renewals, MDEL regulations, 510K registration, to help you run your business smoothly.


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Don’t have time to figure out the regulatory process?

You’re running a drug, food, or medical device facility in the United States. You want to renew your registration.

But you don’t have time to deal with filing the paperwork and getting it all done on your own. Or maybe you’re not sure how to do it properly, so you’re worried that you might not get licensed at all.

How can We Help?

If any of this sounds familiar, then we have good news: Quality Smart Solutions is here to help! We’ll take care of everything for you—from filing the registrations and renewal applications directly with the FDA, handling all interactions with FDA officials, submitting appropriate documentation at all stages of the process, and much more. 

We’ll even ensure that your renewal application gets reviewed by an FDA agent who understands the unique needs of foreign/domestic companies making products in the United States

FDA Facility Renewals for Drug Manufacturers

If you’re a drug manufacturer, re-labeler, or re-packager who is based outside of the United States, this is the service for you.

Our FDA Drug Facility Renewal & Registration service will save you time and money by helping you get licensed faster so that your operations can continue without delays.

We work with FDA officials to help file establishment registrations on behalf of your company and submit them to the FDA through the electronic submissions gateway. We also assist with filing for new product approvals and obtaining certificates of free sale. And we have experienced FDA Drug Facility Renewal Specialists with over 15 years of experience dealing directly with the FDA.

Why should you trust us?

We’ve been working with the FDA for over 16 years, we know exactly what will work best for your business—we’ve seen it all before! From the moment we begin, we listen to and work closely with you to develop a complete understanding of your business objectives. This enables us to create a customized, ideal solution for your business. 

We focus on quality and are passionate about helping companies become more successful. With Quality Smart Solutions, you can trust that all of your food, drug, or medical device FDA Facility Renewal requirements will be fulfilled with ease.

Our FDA Drug Facility Renewal & Registration service will save you time and money by helping you get licensed faster so your operations can continue without delays.

Hear From Our Amazing Clients

Leverage proven expertise. Checkout companies who have trusted us to become regulatory compliant with FDA.

Edward Ro Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Book Your Free Consultation with Our FDA Experts Today

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