Product evaluations & petitions
FDAImports.com consultants and attorneys assist domestic and foreign manufacturers, distributors, exporters, and importers in identifying the relevant federal regulatory requirements for finished products, ingredients, parts and components. Further, our professionals develop compliance plans that ensure necessary agency reviews, evaluations, and petitions are properly prepared and submitted to the relevant authorities
These services may apply to unique food, drug, or cosmetic ingredients, colorants, or flavorings; alcoholic beverage formulations and labeling reviews and approvals; medical device evaluations and classifications; and prescription drug or over-the-counter (OTC) drug monograph requirements; among others.
FDAImports.com assists foreign manufacturers and shippers in preparing and filing petitions for removal from FDA Import Alerts, reducing the delays and costs associated with shipping products to the U.S.
Because of the broad experiences of our former FDA and USDA officials, we are able to provide advice, counseling, and consulting on a wide array of products, processes, and requirements.