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FDA REGISTRATIONS

MADE SIMPLE

Your all-in-one FDA registration portal backend by extensive experience and innovative technology

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FDA Registration

The Food and Drug Administration (FDA) of the United States oversees several other products outside what their name suggests for food and drugs. We help streamline this complicated process.

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Who We Serve

We provide services to a wide array of clients seeking to register and remain compliant with the FDA and its many rules and regulations including, Food & Beverage, Dietary Supplements, Medical Devices, Drugs, Cosmetics and more.

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About Us

The team at UReg – FDA Registrations have over 20 years of combined experience conducting FDA registrations. Their client base includes start ups, privately held multimillion dollar companies, publicly traded companies and everything in between. The team prides themselves on making the difficult and convoluted process of FDA registration easy and straightforward for its customers.

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Our Mission Statement

UReg - FDA Registrations is committed to helping its customers navigate the FDA registration process. We make the process simple and straight forward. We ensure speed and accuracy so that our customers can get back to doing what they do best. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance.
WHAT WE ARE EXPERT AT

Who We Serve

Food & Beverage

Food and beverages companies require registration with FDA depending on the type of operations. Food and beverage regulations are typically regarding safety, facilities, imports, exports and manufacturing of food and beverage items. We save our customers time and money and help them avoid major issues that could come up down the road.
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Dietary Supplements

Dietary supplements (nutraceuticals) are FDA regulated as food. Supplements require FDA registration. Foreign companies also require a US agent. Recently FDA began requesting DUNS numbers for all supplement registrations. We stay current on these changes to help our customers breeze through their FDA registrations and keep their businesses operational and in compliance with FDA regulations.
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Medical Devices

Medical devices are governed by the FDA by a classification process. Each medical device is categorized into one of four classifications, namely Class 1, 2, 3 or unclassified. We will provide you with guidance on product creation, including working with investigators, feedback from third parties, advertisement criteria, and device marketing. In addition, importers, manufacturers and owners of the intellectual property, known as specification developers must all register with FDA. There is an annual fee payable to FDA. We make sure the FDA registrations are completed in a timely manner.
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Drugs

Pharmaceuticals and OTC medications are among the most highly-regulated goods on the market. Via one of the many application procedures, prescription drugs must receive FDA clearance, the most common being New Drug Applications (NDA). Over-the-counter products, also known as OTC, must conform to stringent rules on labeling, production, and additives.
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Cosmetics

The provisions of the Federal Food, Drug and Cosmetic Act, Fair Packaging and Labeling Act, and other federal legislation must conform with cosmetics labeled in the United States. Regulations related to authorized labeling, ingredients, and statements that may be made for cosmetic labeling have been provided by the US FDA.
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Management & Consulting

UReg - FDA Registrations’ experienced management and consulting services assists small businesses and large corporations achieve FDA compliance. The FDA has a number of strict requirements and paperwork involved and our services are designed to streamline the intricate process to ensure products clear all of the necessary hurdles.
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Other

Are you looking to introduce a product to the market? You may need to have it registered by the FDA before proceeding any further. If your product does not fall under a standard category, we can provide assistance with the steps required to receive FDA clearance and avoid legal issues.
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Are you looking for someone to help?

We are here for you. Call now: (786) 504-6363

contact@myfdaregistration.com
·   Mon – Sat 9:00AM – 5:00PM

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    testimonial

    Words From Clients

    • As a company that was trying to enter the market during a difficult time, [they] facilitated this process and made it seamless. They are responsive and very organized.

      Alberto Chamorro
      Arion, LLC

    • My company Concepcion Ventures LLC hired Lisa Capote and her amazing team for all of our company FDA registration, submissions, labels approvals, and other FDA topics.

      Lisa & the team are very knowledgeable with FDA rules and regulations, reliable, and most important very quick to respond and solve issues in a timely matter.

      Highly recommend their services to any company!

      Eran Danino
      Concepcion Ventures, LLC

    • We were up against extremely tight timelines to get some sanitizing products registered with the FDA, and Lisa and Andrina guided us through the entire process with quick response and expert advice. We’ve tried dealing with the FDA on our own in the past, and found it to be confusing, frustrating and time consuming. It is truly a comfort to know that we have them to rely on, and have time and time again. We count on them for anything concerning the FDA, and have been able to increase our business exponentially through their assistance and professional guidance. We couldn’t ask for better partners!

      T.J. Ashcraft
      Snaproducts Regulatory and Compliance Manager

    • The team….has been an invaluable partner helping us navigate the complexities of FDA regulations as our company transitions to making hand sanitizer and other OTC products. From simple product registrations to advice on developing an overall compliance and documentation program, they are always helpful and responsive with thorough and thoughtful advice. We highly recommend [them] to anyone in need of compliance solutions for FDA-regulated products.

      Tom Savage
      Dyno Manufacturing

    • Nuestra experiencia…, ha sido más que extraordinaria, el servicio prestado tanto por Lisa Capote como Andrina Capote es de primer nivel, para nuestra compañía Alimentos Ideal S.A. nos han apoyado con todo lo relacionado a los trámites de FDA, desde el registro de nuestras plantas hasta revisiones de etiquetas. Son un equipo muy profesional, te explican todo el proceso y sobre todo aclaran las dudas que te puedan surgir en el mismo, su nivel de respuesta es rápido y atiende tus consultas en cualquier momento, sin duda les recomendamos para cualquier asesoramiento o trámite FDA que necesiten realizar.

      Jonathan Carlos Rolando Soto Cruz
      Alimentos Ideal, S.A.

    Request a Consultation

    Contact our team today regarding your FDA registration needs and get a free consultation.

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