Problems We Solve: Starting a Regulated Business

Entering the U.S. market can be intimidating. There are many aspects to successfully importing and distributing FDA- or USDA-regulated products. We can help you with a wide variety of operational issues, based on your overall market strategy and business goals. Of key concern are issues such as determining the best U.S. business entity structure and preparing and filing business entity formation documents. U.S. trademark or patent availability analysis, risk analysis, and trademark/patent filings will impact your market strategy as well.

Clients rely on our legal business counsel to ensure that their products comply with complex U.S. law and regulatory requirements in order to enter the market with minimal regulatory interference and remain in the market with minimal litigation risk.

  • Corporate Counsel­­
    • Choice of entity
    • Jurisdiction
    • Tax
    • Federal, state, local filings
    • Registered agent/signatory
  • Commercial Counsel
    • Distribution Contract
    • Sales Contract
  • Insurance
    • Audit
    • Coverage analysis
    • Solicitation/Broker
  • FDA Compliance
    • Facility registration
    • Regulatory review
    • Label review
    • Premarket obligations
    • HARPC, HACCP, cGMP, SOP review
  • USDA
    • Permits
    • Labels
  • Intellectual Property
    • Trademark filing
    • Trademark search
    • Trademark infringement opinion
  • Sales/Marketing
    • Website design
    • Search Engine Optimization
    • PPC campaign management
    • Offline content development
    • Pricing analysis
  • Importer of Record/Customs/Logistics
    • Importer of Record (IOR)
    • Harmonized Tariff Schedule (HTS)
    • Broker management
    • Freight Forward work/logistics/freight transport
  • Accounting/Tax/Back Office
    • Start up
    • Reporting and financial analytics
    • Operations – P/L, sales, distribution
    • Banking