People We Serve: Manufacturers

You want to ship quality products, on time and within budget. Keeping up with the registrations, permits, and other potential regulatory complications involved in a global market can be a frustrating burden – not to mention tracking supplier agreements or intellectual property rights. Our team can handle legal and regulatory solutions for your manufacturing operation, and let you get on with what you do best.

  • Expedite the supply chain process so that your products can get into the U.S. from your manufacturing facility through the import transaction to the end-user or consignee
  • File and maintain facility registrations, product listings, and permits
  • Identify and secure intellectual property rights
  • Advise on regulatory requirements and provide insight on how regulators interpret and implement the requirements
  • Evaluate transactions from the perspective of regulatory agencies (FDA, USDA, CBP) and ensure that documents are designed to minimize regulatory delays at the border
  • Evaluate or prepare legal contracts, including distribution and exclusivity agreements
  • Examine the compliance history of your suppliers and make recommendations for risk management
  • Guide you through the FDA inspection process

 

cGMPs Labeling HACCP Quality Systems
SOPs 510(k) QSR Import Manuals
HARPC DQSA VQIP Warning letters
Import Alerts FSVP FDA Holds Formulation