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How To Register With The FDA October 18, 2019

The US FDA requires facilities who are engaged in manufacturing, processing, packaging or storing food pharmaceuticals, and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facility and list the products. Companies must annual renew the registration and listings.  FDA US agent is required … Continue reading How To Register With The FDA

Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures June 26, 2019

The FDA stands for Food and Drug Administration. FDA is a crucial part of the US Department that is dedicated towards offering health and human services. The primary function of this organization is to oversee the production of foods, pharmaceuticals, medical devices, and other consumer products.  The development of biological commodities that are used for … Continue reading Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures

All You Need To Know Responsibilities Of An FDA US Agent April 30, 2019

In the United States, FDA US Agent plays an important role in regulatory compliance activities. Further, regulatory compliance has a direct impact on your business. It remains U.S Agent responsibility to assist FDA to communicate with foreign companies when such communication is necessary. U.S Agent should be capable of understanding FDA compliance related matters and effectively communicate with foreign companies.

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