Assistance with FDA Regulations
Looking for help in navigating FDA Requirements? Registrar Corp is here to help.
We understand that U.S. Food and Drug Administration (FDA) guidelines can be challenging to understand. Registrar Corp has been helping businesses navigate US FDA regulations and laws since 2003. Our Regulatory Specialists have aided more than 30,000 companies across 160 countries. Employees include former U.S. FDA officials, scientists, and industry experts.
Registrar Corp offers a wide variety of services for all FDA-regulated industries. Whether you need assistance with FDA requirements for labeling, registration, or other FDA regulations and laws, we are ready to assist.
FDA Regulations for Food
Facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States must register with FDA. Food facilities must also follow FDA requirements for labeling, develop written Food Safety Plans, and more.
Registrar Corp can assist companies to comply with these US FDA guidelines. We can register facilities with FDA and act as the U.S. Agent for non-US facilities. Registrar Corp can also assist facilities with developing Food Safety Plans, labeling, prior notice, and other FDA requirements for food.
FDA Regulations for Cosmetics
Registrar Corp can assist companies with registration of Cosmetics Product Establishments through the FDA’s Voluntary Cosmetics Registration Program (VCRP). We also provide assistance with cosmetic FDA requirements for labeling cosmetics, FDA Cosmetics Product Ingredient Statement (CPSI) filings and required reporting with the California Safe Cosmetics Program.
FDA Regulations for Drugs
Drug establishments with products intended for use in the United States must register their establishments and list their products with FDA.
Registrar Corp can register drug establishments with FDA, list drug products with FDA, and assist with FDA requirements for labeling. Drug labels must be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. We also offer guidance on submitting Drug Master Files to the FDA.
FDA Regulations for Medical Devices
Medical device establishments with products intended for use in the United States must register their establishments and list their products with FDA.
Registrar Corp can help medical devices establishments meet FDA Guidelines. We offer assistance with FDA registration and listing, UDI and GUDID requirements, submitting US FDA Electronic Medical Device Reporting (eMDR), and Medical Device Master files.
To learn more about how Registrar Corp can help your company with FDA Guidelines simply complete the form below
