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What You Need To Know About The FDA GDUFA Self Identification Requirements April 30, 2019

Who is required to self-identify?As per the federal law, FDA self-identification is going to start from May 1st, 2019 and the facilities are required to submit their files as soon as possible. Each and every Drug company is requested to update, re-confirm and submit the self-identification form before June 1st, 2019. The manufacturer or any company who plans to become a manufacturer of human generic drug APIs or FDFs are required to self-identify. Any organization or company that package the FDF of human generic drugs into the primary container/closure system will also have to go through this process..... Read More

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. .... Read More

All You Need To Know About The FDA Food Facility Registration March 12, 2019

The Bioterrorism act that was introduced in the year 2002 is meant to check the flow of food and drugs under the Food and Drug Administration (FDA) which is one of the most popular food regulatory agencies in the world. These services were meant to protect the public from food-related emergencies and keep a check on the common issues among the people..... Read More

February 9, 2019

US FDA Registration services in India. We have started our office in India to provide assistance to our Indian customers who are looking for FDA registration. Now you can contact with our  representative in your country for US FDA registration in India. Our  technical expert team in India can help you to understand FDA requirements … Continue reading .... Read More

Requirements for selling food products in the USA January 21, 2019

Food Facility Registration If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility. Pragmatic Compliance LLC shall act as U.S Agent for food facility registration purpose and register the facility. Our fee for food facility registration including … Continue reading Requirements for selling food products in the USA .... Read More

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