United States of America (USA) is renowned for being highly regulated market for Medical Devices with well-defined registration pathways and requirements. The initial medical device regulations of the U.S. date back to 1976 and have evolved over period. They are regulated by the Centre for Devices and Radiological Health (CDRH) under the Food and Drug Administration (FDA). Freyr has helped multiple device manufacturers to comply with the US FDA medical device registration process.

Freyr, with a team of Qualified Regulatory experts, provides Cosmetics regulatory services in the USA such as Product Classification, FDA Cosmetic Claims Review, and Cosmetic Label Review as per the FDA Cosmetic Labeling Requirements, which are crucial for the establishment of Cosmetics in the USA. Headquartered in the USA, Freyr assists Manufacturers with quick Market Access based on Product Type. Freyr helps in aligning with the FD&C Act and MoCRA and extends Post-Marketing Surveillance support for cost-effective Adverse Event Tracking and Reporting.

The United States (US) is a compliance-based market for food and dietary supplements. The products are regulated by the Federal Register and the Code of Federal Regulations (CFR), Title twenty-one (21). It is the legal authority of the US Food and Drug Administration (USFDA). Food and dietary supplements do not require pre-market approval, but the USFDA has a strict Regulatory policy for evaluating these products through adverse event monitoring and research. Manufacturers of novel products and novel ingredients are required to submit a pre-market notification to the USFDA via the Generally Recognised as Safe (GRAS) notification and the New Dietary Ingredient Notification (NDIN).

Handling chemical products to minimize the risk to human beings and the environment is challenging. Many countries, including the USA, incorporate complex Regulatory processes to adhere right assessments for potential hazards in the chemical products for humans and the environment during production, processing, and distribution. In such scenarios, manufacturers must consider the GHS frameworks and information on various country-specific approaches for the risk management of chemical products.