ALBA HAS THE CURE FOR COMPLEX MEDICAL REGULATIONS

If you plan to import medical devices as well as PPE into the United States, you know that navigating through complex FDA regulations and requirements can be a veritable minefield.

You need a highly experienced partner to smooth the way. A partner that can serve as a qualified US agent and liaison between foreign manufacturers and the FDA. A partner that can leverage longstanding relationships with the FDA and CBP to expedite the entry review process.

A partner that can provide sophisticated customs brokerage services that are engineered for FDA and CBP oversight through ACE (Automated Commercial Environment). That partner is Alba Wheels Up.

THE ALBA ADVANTAGE
  • We expertly navigate through the latest PPE import regulations
  • We know your product definitions and manage the process between FDA enforcement policy vs. FDA emergency use authorization
  • We are experienced in the multi- agency importation of face shields, face masks, surgical masks, n85 respirators, NIOSH approved n95 respirators, personal wipes, surface wipes, hand sanitizers, and nitrile gloves
  • We are experts at goods covered under the FDA emergency use authorization
  • Our PPE customers enjoy speed to market, due to reduced delays