FDA Registration Assistance Recensioni 

Scritti dall'azienda

FDA Registration Assistance is a leading U.S.-based regulatory compliance consulting firm specializing in FDA registration, U.S. Agent services, Foreign Supplier Verification Program (FSVP) compliance, cosmetic MoCRA compliance, medical device registration, drug establishment registration, FDA label reviews, food process filings, and import compliance support for companies seeking access to the United States market. Since 2013, FDA Registration Assistance has helped manufacturers, exporters, importers, distributors, brand owners, e-commerce sellers, and Amazon businesses navigate complex U.S. Food and Drug Administration (FDA) requirements. Our team works with businesses of all sizes, from startups launching their first product in the United States to multinational companies managing large-scale regulatory compliance programs across multiple facilities and product lines. With clients in more than 135 countries worldwide and over 1,000 companies served, FDA Registration Assistance has developed a reputation for providing practical, responsive, and business-focused compliance solutions. We understand that regulatory requirements can be overwhelming, especially for foreign companies unfamiliar with FDA regulations, and our goal is to simplify the process while helping clients remain compliant and avoid costly delays, detentions, refusals, and enforcement actions. Our services cover a wide range of FDA-regulated industries, including food and beverage products, dietary supplements, cosmetics, pharmaceuticals, over-the-counter (OTC) products, medical devices, seafood, low-acid canned foods, acidified foods, pet foods, and ingredients intended for the U.S. market. Our Core Services FDA Food Facility Registration We assist domestic and foreign food facilities with FDA Food Facility Registration requirements under the Food Safety Modernization Act (FSMA). Our team helps facilities obtain and maintain active FDA registrations, manage renewals, and remain compliant with FDA registration requirements. U.S. Agent Services Foreign facilities registered with the FDA are required to designate a U.S. Agent. FDA Registration Assistance serves as a professional U.S. Agent for food facilities, medical device establishments, pharmaceutical companies, and cosmetic facilities, acting as a communication point between clients and the FDA. Foreign Supplier Verification Program (FSVP) We provide comprehensive FSVP services for U.S. importers, including FSVP Plan development, supplier verification activities, hazard analysis reviews, importer compliance support, FDA inspection preparedness, and ongoing FSVP consulting. Our FSVP services help importers meet their responsibilities under FSMA and reduce the risk of shipment delays or FDA enforcement actions. Cosmetic MoCRA Compliance The Modernization of Cosmetics Regulation Act (MoCRA) introduced significant new requirements for cosmetic companies selling products in the United States. FDA Registration Assistance assists with cosmetic facility registration, cosmetic product listing submissions, Responsible Person support, adverse event reporting guidance, and cosmetic label compliance reviews. Medical Device Registration & Listing We support medical device manufacturers, specification developers, contract manufacturers, repackagers, relabelers, and initial importers with FDA Establishment Registration and Device Listing requirements. Our services include registration assistance, listing preparation, U.S. Agent services, and regulatory guidance related to FDA medical device compliance. Drug Establishment Registration & NDC Services For pharmaceutical and OTC drug companies, we provide assistance with Drug Establishment Registration, National Drug Code (NDC) Labeler Code applications, NDC listings, Structured Product Labeling (SPL) submissions, and annual registration maintenance requirements. FDA Label Reviews Accurate product labeling is essential for FDA compliance. We conduct detailed label reviews for food products, dietary supplements, cosmetics, OTC products, and medical devices. Our reviews identify potential compliance concerns related to ingredient declarations, nutrition labeling, allergen statements, claims, directions for use, warning statements, and other regulatory requirements. FDA Process Filings (FCE & SID) For manufacturers of low-acid canned foods and acidified foods, we assist with Food Canning Establishment (FCE) registration and Submission Identifier (SID) process filings. These filings are often required before products can legally enter U.S. commerce. Amazon FDA Compliance Many Amazon sellers face product listing removals, compliance requests, or regulatory concerns related to FDA-regulated products. We provide Amazon compliance reviews covering product labels, product listings, images, claims, bullet points, descriptions, A+ content, and supporting documentation to help sellers address compliance concerns and reduce regulatory risk. Import Compliance Support We assist importers, customs brokers, manufacturers, and distributors with FDA import requirements, including shipment compliance reviews, FDA detention responses, Import Alert guidance, Prior Notice questions, and regulatory documentation support. Industries We Serve FDA Registration Assistance works with businesses across a broad range of industries, including: Food Manufacturers Food Warehouses Food Distributors Dietary Supplement Companies Cosmetic Brands Personal Care Manufacturers Amazon Sellers E-Commerce Businesses Pharmaceutical Companies Medical Device Manufacturers Seafood Processors Beverage Companies Ingredient Suppliers Pet Food Manufacturers Contract Manufacturers Private Label Brands Importers and Exporters International Manufacturers Entering the U.S. Market Why Companies Choose FDA Registration Assistance Businesses choose FDA Registration Assistance because we combine regulatory knowledge with a practical understanding of international trade and business operations. Our team understands the challenges companies face when navigating FDA requirements, and we focus on delivering clear guidance, responsive communication, and efficient project management. Our commitment is to help clients understand what is required, avoid common compliance mistakes, and move products into the U.S. market as smoothly as possible. Our Mission Our mission is simple: to make FDA compliance more accessible, understandable, and manageable for businesses around the world. We strive to provide reliable regulatory support that allows our clients to focus on growing their businesses while maintaining confidence in their compliance efforts. Whether you are registering a food facility, establishing an FSVP program, listing cosmetic products under MoCRA, registering a medical device establishment, obtaining an NDC labeler code, reviewing product labels, or preparing products for sale on Amazon, FDA Registration Assistance is committed to helping you navigate the regulatory process with professionalism, transparency, and dedicated support. FDA Registration Assistance Founded: 2013 Headquarters: Miami, Florida, USA Clients Served: 1,000+ Countries Served: 135+ Worldwide Specialties: FDA Registration, U.S. Agent Services, FSVP Compliance, MoCRA Compliance, Medical Device Registration, Drug Registration, FDA Label Reviews, Food Process Filings, Amazon FDA Compliance, and Import Regulatory Support.Leggi di più