U.S. based distributors
are often seeking new products to introduce into
their product lines. In many cases, these
products may not yet be FDA approved. O’Connell
Regulatory Consultants can work directly with
the international manufacturer and assist in
preparing the necessary documentation which can
then be sent to FDA in order to allow the new
products to be FDA cleared. Once you have an
approved product, it will be allowed through
customs and can be legally sold in the United
States. |