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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

Is Ebola Making FDA Concerned ?? November 2, 2016

In July ‘14 FDA in their compliance guidance for manufacture of drugs paid added attention to the NTDs. The Neglected Tropical Diseases. Most of these diseases are confined to the developing world and where the surroundings play an important role..... Read More

EDQM Updated CEP Revision And Renewal Guideline. November 2, 2016

EDQM update their guideline for Revision and Renewal of CEP. The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs”..... Read More

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