The United States stands as an industry hub for the Life Sciences sector. With continuous innovation and growth, the country showcases significant potential for foreign medicinal products’ and medical devices manufacturers. As a well-established regulated market, the U.S. obliges manufacturers to adhere to the United Sates Food and Drug Administration’s (US FDA) stringent guidelines for compliant market entry. However, given the country’s dynamic Regulatory landscape with respect to registration procedures, technological advancements, and GxP best practices, keeping pace with continuous updates and compliant procedures might be challenging for foreign manufacturers.

Headquartered in New Jersey, USA, and having proven expertise in the U.S. Regulatory affairs, Freyr assists manufacturers to navigate the ever-evolving and stringent Regulatory procedures. Freyr’s Regulatory services in the United States span across following product categories such as:

  • Medical Devices
  • Pharmaceuticals
  • OTC
  • Cosmetics
  • Food & Food Supplements
  • Biotechnology and Biosimilars

Freyr Expertise

  • Strategic Regulatory Consulting
  • Regulatory Roadmap for Market Access
  • Regulatory Affairs & Regulatory Intelligence
  • Registration Pathways and License Management
  • Lifecycle Maintenance: Variations, Renewals, Notifications
  • Regulatory Publishing and Submissions
  • Regulatory Labeling & Artwork Pack Management
  • Medical and Scientific Writing
  • Compliance Audit and Validation

Freyr Advantages

  • Expert Regulatory team with proven global RA expertise
  • Strong regional presence
  • Proactive and collaborative approach
  • Quick turnarounds and faster time-to-market