FDA Registration

For companies looking to establish a presence in the U.S. market, there are several federal laws and regulations that manufacturers must adhere to before and after marketing/selling their products. At Taksim Consultancy, we provide essential services to help manufacturers obtain FDA (Food and Drug Administration) registration for their products and marketing materials, ensuring compliance with all FDA procedures.

What is FDA Registration?

The FDA, part of the U.S. Department of Health and Human Services, oversees biological products, medical devices, cosmetic products, and radiation-emitting products, aiming to protect public health. In addition to accelerating innovations that make medical products and foods more effective, safer, and more economical, the FDA assists in obtaining accurate, scientifically based information on their use. Foreign companies must appoint a U.S. representative for FDA communications.

FDA U.S. Representation

Within Taksim Consultancy, we offer services to global clients, including label and content reviews, FDA registrations, pre-market notifications, renewal requests, responses to warning letters, and more. We establish a robust communication and information network to ensure the timely and complete acquisition of all necessary documents by closely monitoring FDA regulations.

FDA Food Facility Registration

FDA food facility registration is mandatory for all facilities producing, processing, packaging, or storing food, beverages, or dietary supplements for consumption by humans or animals in the U.S. This registration has become necessary under the Bioterrorism Act (BTA). Non-compliance with BTA may result in the refusal of importation of food or beverages produced by a foreign facility not registered under BTA. The steps taken to comply with this process are referred to as food facility registration.

FSMA Services

With the Food Safety Modernization Act (FSMA), FDA regulations regarding food safety have evolved. While registration is required only once for each food facility, FSMA mandates biennial registration renewal for all food facilities. We guide companies in the food, beverage, and dietary supplement sectors through mandatory steps such as audits (FSVP), hazard analysis, food safety planning (HRCP), food defense planning, and FSVP, ensuring the acquisition of necessary certifications. We keep abreast of FDA’s continuous updates and maintain a flow of up-to-date information.

FDA Labeling Requirements

FDA defines labeling as “any written, printed, or graphic matter accompanying an article or appearing on the container or wrapper.” Labeling errors are a leading cause of FDA observations. Taksim Consultancy assists our partner companies in changing food, beverage, or dietary supplement labels to comply with FDA regulations. We share our expertise on revised graphic files ready for printing or editing, regulations, compliance guides, warning letters, import alerts, and other guide documents.

FDA Medical Device Registration

Before importing medical devices into the United States, they must meet all FDA regulations. One critical consideration for foreign medical device manufacturers is that FDA does not recognize legal approvals from foreign countries. Medical devices are classified into three categories based on the risk of harm to the patient or user. Determining or obtaining the correct classification for medical devices is crucial for all manufacturers and distributors.

FDA Hand Sanitizer

For antiseptic hand sanitizers, FDA compares the risks and benefits of active ingredients under specific conditions to determine their generally safe and effective use. During the COVID-19 pandemic, FDA updated regulations for these products. FDA approved 28 active ingredients for over-the-counter antiseptic hand sanitizers, and manufacturers using these ingredients require FDA approval to continue marketing. Foreign hand sanitizer manufacturers need to complete registration and drug listing before entering the U.S. market. This rule, however, does not include antiseptic washes, healthcare antiseptics, first aid antiseptics, or antiseptics used in the food industry.

FDA Drug Registration

The FDA’s Center for Drug Evaluation and Research (CDER) evaluates and registers drugs intending to be marketed in the U.S., whether prescription, over-the-counter, or sold over-the-counter. Therefore, owners or operators of all drug-producing organizations in the U.S. and abroad that deal with the manufacture, preparation, propagation, compounding, or processing of any drug must undergo an evaluation process for each drug intended for commercial distribution in the U.S.

In this process, companies must submit a New Drug Application (NDA) to introduce a new drug product to the U.S. market. The goal of the NDA is to provide sufficient information for the FDA reviewer to make a decision. This information addresses the safety and effectiveness of the drug’s use, whether its benefits outweigh its risks, the suitability of its proposed labeling, and the methods used in its production.

FDA Required for Cleaners and Fragrance Products

Taksim Consultancy guides companies in following the necessary steps to comply with FDA regulations, ensuring adherence to FDA content and labeling requirements for drugs, preparing compliance guides, warning letters, and supporting the preparation of a drug master file that can be used for pre-market submissions to provide detailed, confidential information about facilities, processes, or products used in the manufacture, processing, packaging, and storage of one or more drugs.