Why do You Need FDA Establishment Registration Medical Device Listing Consultants?

Any establishment engaged in the manufacture, importation, reprocessing/relabeling, or development of specifications for an IVD or medical device for commercial sale in the United States must register annually with the United States Food and Drug Administration (FDA). In the United States, owners and operators of companies involved in the manufacture and distribution of medical devices, drugs, combination products, dietary supplements, or cosmetics must register with the FDA each year. These administrative tasks, FDA establishment registration, and medical device listing are tedious and often overlooked, resulting in delays and errors in registration certificates, which can affect the ability to sell products.

Facilities that are needed to register with the FDA must also list the medical devices they manufacture in the US FDA Listing and Registration Database. This US FDA medical device listing and registration database help the US identify manufacturing facilities and the products they manufacture, which will help us better prepare for cases including public health emergency. Our best FDA Establishment Registration Medical Device Listing Consultants are here for all your registration & listing of your medical device to the FDA needs.

Our Aim And Commitment

Our mission is simple: get our customers' products to market and keep them there. Thomas Regulatory Resolutions has been providing companies with strategic advice on how to effectively navigate the medical device, pharmaceutical, nutraceutical, and cosmetic regulations around the world. We operate as a family business, which means that our customers are always our top priority. We understand the frustration and confusion that comes with navigating medical devices, which is why we're always here to assist our customers. We are not too busy to answer the phone, email, or meet in person. Thomas Regulatory Resolutions is with you and most of all, we want to see you and your product succeed.

Our goal has always been the same: to execute the most effective and profitable marketing route for our customers around the world. We like to say that we are a "one-stop shop", providing not only management solutions but also clinical and quality solutions. Instead of training our consultants in a variety of specialties, we prefer to work with a larger team where each person has their niche and they are well trained. This means you always get 110% for working with us. We are proud to have a team from a variety of backgrounds including SaMD, IA, Cardiology, Orthopedics, Pharmaceutical, Cosmetics Veterinary Medicine, and Environmental Nutrition.

Conclusion

For help with enrollment and registration, contact one of our experienced FDA Establishment Registration Medical Device Listing Consultants at Thomas Regulatory Resolutions today! and don't forget to register your medical device with the FDA. To avoid registration interruptions, be sure to renew your US FDA Establishment Registration and Medical Device List with FDA. We recommend applying by December 1 to allow time for processing, especially during these uncertain times when things take longer than usual. In addition, we can register your facility with the US FDA and of course the medical device listing.

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How Do an FDA US Agent and Establishment Registration Medical Device Listing Consultants Work?

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