People We Serve: Distributors/Exporters

Both distributors and exporters face regulatory obstacles to their objectives of moving product efficiently. Even the most prepared companies can encounter unforeseen regulatory oversight from agencies like FDA and Customs, such as random manufacturer inspections or shipment detentions.  We work with you to minimize the impact on your business operations.

  • Provide training for operations, regulatory affairs, and import and traffic personnel.
  • Manage FDA import holds, detentions, and import alerts to minimize interference with business operations
  • Evaluate transactions from the perspective of regulatory agencies (FDA, USDA, CBP) and ensure that documents are designed to minimize regulatory delays at the border
  • File and maintain facility registrations, product listings, and permits
  • Advise on regulatory requirements and provide insight on how regulators interpret and implement the requirements
  • Examine the compliance history of your suppliers and make recommendations for risk management
  • Evaluate or prepare legal contracts, including distribution and exclusivity agreements
  • Conduct label reviews and evaluate marketing claims of products to be exported
  • Provide counsel on formulations (i.e. color additives) and GRAS notifications
  • Guide you through the FDA 510(k) or pre-market notification (PMN) process