Understanding Pharmaceutical FDA Compliance

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(Newswire.net — March 9, 2015) Oakland, California — The pharmaceuticals are a large and ever increasing industry. To manage such a complex industry, the FDA needs to oversee the production and distribution of these medical products. Global Biopharm is a relatively new company established in 2000 to help both small and large companies comply with the ever changing rules and regulations. This is not an easy task for a manufacturing company to do themselves. The manufacturing company is doing the work of producing medications.

Global Biopharmaceutical Regulations Inc. has a continual process of learning new regulation and how to comply with these regulations. Global Biopharm uses there expertise to help both national and international companies document their work and monitors compliance with the many regulation for clinical and manufacturing of medications. The will supply certification that there is Quality Control of the contract manufacturing. Their audits are outstanding.

People want to feel safe about the Medicine that they use to maintain their health and wellness. Doctors want to be assured that they are prescribing medication that is monitored and controlled for excellence and compliance with the standards set by the FDA. Everyday new drugs are coming on the market. Consumers as well as doctors need to trust these new drugs. Drug companies study the drugs and write the results of these studies. These clinical studies are very important to the viability of the drug for us by consumers. But it is the FDA that assures the contents of the drugs and the accuracy of the test results.

Global Biopharm audits drug companies which is a great help to the companies. If there is a problem discovered by Global Biophar, then the drug company can correct the problem before it becomes a problem with the FDA or in the marketplace. The Over-the-counter drugs also need monitoring, and Global Biophar will do the oversight for these products. What is in the containers of drugs sold is printed on the white label. Labels also must be examined for accuracy of content. American Society for Quality (ASQ) is an organization that is both global and dedication to achieving quality in all their endeavors. They contribute to the quality of our medical products.

About  

Global Biopharm Regulations was founded in 2000. The focus of the practice is to serve the biopharmaceutical regulated industry. We specialize in regulatory affairs consulting and quality compliance and oversight. We also provide services for over-the-counter (OTC) medications and other neutraceuticals. Our goal is to develop long-term relationships by providing comprehensive drug development strategies to accelerate time to approval.

 

 
Oakland, California United States 94610

(510) 388 4027
info@biopharmregulations.com
http://www.biopharmregulations.com