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FDA Self Identification For The Year 2016 Started. November 2, 2016

As required by Generic Drug User fee act FDA self identification period  for fiscal year  2016 starts on May 1s  2015, and companies can self-identify their facilities till  June  1st ,2015..... Read More

FDA Conslutants November 2, 2016

Tobias has many years of experience as FDA consultant, we provide FDA consulting services for food, drug, medical device, cosmetic and plastic companies. We understand that , aim of all the regulatory compliance is to bring your products to the markets.... Read More

NDC Number Format November 2, 2016

NDC (National Drug Code) is 10 digit number which is grouped in three sets. First set of five or six  digits  corresponds to labelar code, which FDA assigns to the labelar, such labelar code identifies the labelar or responsible owner of the drug..... Read More

Drug Establishment Registration Renewal November 2, 2016

As per 21 CFR 207, companies who manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S are required to register their facilities and are required to keep the information updated..... Read More

US FDA Regulatory For Approval In Medical Devices November 2, 2016

FDA is the established ultimate authority for providing approval for manufacture of import of medical devices in US. The Congress also appoints it to charge certain fees for this work from the license seekers. The fee is not fixed but is determined in the preceding year’s middle months..... Read More

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