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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 .... Read More

A Guide to ANDA Submissions Issued By The FDA June 5, 2019

ANDA stands for Abbreviated New Drug Application. The ANDA submission is known to contains Chemistry, Manufacturing and Control information along with bio-equivalence data . The main purpose of the ANDA submission to the FDA is to review as well as ensure potential approval of generic drug the FDA. Once the drug or product receives approval, … Continue reading A Guide to ANDA Submissions Issued By The FDA .... Read More

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

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