Explore Our Services

North Haven Import & Compliance Group provides specialized regulatory support for companies importing food, dietary supplements, pharmaceuticals, and medical devices into the United States. We help businesses navigate the complex FDA and U.S. Customs requirements that govern product entry, ensuring smooth, compliant, and timely importation.

Our services include import documentation review, product classification guidance, facility registration support, Prior Notice submissions, medical device listing and registration assistance, and resolution of FDA or Customs holds. With a focus on accuracy, transparency, and regulatory expertise, we help domestic and international manufacturers avoid delays, mitigate compliance risks, and maintain consistent market access.

Whether you’re shipping your first product into the U.S. or managing ongoing distribution, North Haven delivers reliable, knowledgeable support that keeps your imports moving

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What We Offer

  • FDA label review support services that help businesses evaluate product labels for regulatory alignment, required elements, and compliance readiness for FDA-regulated products

  • FDA U.S. Agent and Official Correspondent support services for foreign manufacturers requiring a dependable U.S.-based FDA point of contact to support regulatory communications and compliance coordination

  • We provide FSVP Agent support services to help foreign food suppliers and U.S. importers navigate FDA Foreign Supplier Verification Program requirements and prepare for compliant food importation into the United States.

  • North Haven Imports & Compliance Group LLC offers regulatory support services for businesses importing regulated products into the United States. Our focus includes food, drug, and medical device imports subject to FDA and U.S. Customs requirements.

  • Item descriptionNorth Haven Imports & Compliance Group LLC provides regulatory support services for companies acting as Initial Importers of medical devices into the United States. We assist businesses in understanding and meeting FDA requirements associated with importing finished medical devices and device components into U.S. commerce.

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