Thomas Regulatory

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the U.S. Food and Drug Administration authorized the emergency use of certain health products under certain circumstances. Our FDA Emergency Use Authorization EUA consultant is authorized to assist in emergency preparedness and response, including the development and delivery of new or unapproved medical products (drugs, biologics, and medical devices) for use in emergency situations. The Thomas Regulatory Resolution Team supports EUA applications and strategies with a solid understanding of FDA requirements for EUA related to COVID-19; we continue to keep up with changing requirements as they evolve during this emergency due to the current global corona virus pandemic. From providing strategic roadmaps for navigating different EUAs for COVID-19 products to developing commercial use plans for products available under the EUA, the Regulatory Resolutions of Thomas can advise clients on how to achieve their specific short- ...

Owners and operators of businesses involved in the manufacture and distribution of medical devices, drugs, combination products, dietary supplements, or cosmetics in the United States must register with the FDA annually. These administrative tasks, FDA medical device consultant , are time-consuming and often overlooked, leading to delays and errors in registration certificates, which can affect their ability to sell their products. In general, facilities that are required to register with the FDA must also list the medical devices they manufacture in the US FDA Listing and Registration Database. Thomas Regulatory Resolutions Instituted by the FDA's Registered Medical Devices Consulting Firm, help the United States identify manufacturing facilities and the products they manufacture, allowing us to prepare effective more effective for public health emergencies. Thomas Regulations consultant Owners or operators of premises (also known as facilities or facilities) involved in the manu...