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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

Purple Book For Licensed Biological Products November 2, 2016

FDA has published purple book containing list of licensed biological products with reference   product, and biosimilarity. The lists includes the date on which biological product was licensed under PHS Act and whether FDA evaluated the biological product.... Read More

FDA’s Policy On Communicating Drug Approval Information November 2, 2016

FDA’s has made effective manual procedure and policy for communicating drug approval information. Considering interest of industry and FDA including press an other international counter parts FDA will make drug approval.... Read More

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