PaxMed International, LLC announces the launch of a new service for its international clients. PaxMed has registered with FDA as an Initial Importer and will serve in this role for clients who wish to export to the United States. This means that a manufacturer wishing to export to the United States is not confined to using distributors who are willing also to accept the regulatory burden of serving as an Initial Importer. The regulatory responsibilities of an Initial Importer are significant and distributors who may be outstanding at marketing products may not have the resources or experience to meet FDA requirements. PaxMed has implemented an FDA-compliant Quality System that guides it in dealing with complaint handling and the required reporting of certain complaints to FDA, as well as with all other FDA requirements.
If you are interested in exploring the use of this new PaxMed International service, please contact Jim Duvall at jduvall@paxmed.com, or at +1 (858) 792-1235.