Regulatory Compliance
Our
Services.
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Know all the solutions and services that EPort USA has for your products.
Foods
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The United States Food and Drug Administration (FDA) is responsible for ensuring that foods sold in the United States are safe, healthy, and properly labeled. This applies to food produced in the country, as well as food from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the federal laws that rule food products under the jurisdiction of the FDA.
In order to export a food product to the United States, it is necessary to have an establishment registration, an agent representation with the FDA and adequate labeling for the products.
OTC Products
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National and foreign establishments that manufacture, repackage, or re-label pharmaceutical products (over-the-counter-OTC or prescription) in the United States must register with the FDA annually. They should also list all of their marketed drug products. Pharmaceutical products that are not listed correctly as required or are mislabeled may be subject to regulatory action.
Food
Supplements
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The FDA regulates food supplements under a different set of regulations than those covering "conventional" foods (prescription and over-the-counter). Under the Food Supplement Health and Education Act of 1994 (DSHEA), the manufacturer of the supplement is responsible for ensuring that a dietary supplement is safe before being marketed. In order to export a food supplement to the United States, it is necessary to have an establishment registration, an agent representation with the FDA and adequate labeling for the products.
Drugs
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National and foreign establishments that manufacture, repackage, or re-label pharmaceutical products (over-the-counter-OTC or prescription) in the United States must register with the FDA annually. They should also list all of their marketed drug products. Pharmaceutical products that are not listed correctly as required or are mislabeled may be subject to regulatory action.
Cosmetics
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The FD&C Act defines cosmetics as products intended to be applied to the human body to cleanse, beautify, promote attractiveness, or alter appearance without affecting the structure or functions of the body. This definition includes products such as skin creams, lotions, perfumes, lipsticks, nail polishes, preparations for eye and facial makeup, shampoos, permanents, hair dyes, toothpastes, deodorants and any material intended for be used as a component of a cosmetic product. Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. It is the responsibility of the company to ensure that its cosmetic products and ingredients are safe and properly labeled, in accordance with the law.
Medical
Devices
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Owners or operators of establishments or facilities involved in the production and distribution of medical devices intended for use in the United States must register with the FDA annually.
Most of the establishments that must register with the FDA must also list the devices that are manufactured there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the United States, then the owner / operator must also submit the FDA premarket listing number (510 (k), PMA, PDP, HDE ).
EPA Antimicrobial
pesticide registration
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Obtaining new company numbers and registering establishment numbers
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Developing registration strategy including assessment of data requirements, costs of pursuing registration, schedule, and the most efficient regulatory path.
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Developing protocols and placing and monitoring chemistry, toxicity, and efficacy testing necessary to meet EPA data requirements
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Preparing applications with all necessary forms and documents, including confidential statements of formula and proposed labels, in consultation with clients
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Preparing “me-too” applications (i.e., registrations substantially similar to existing registered products)
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Preparing device applications
FDA Registration - Antibacterial Gel, Topical Sanitizers, OTC (Over the Counter) Products.