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Monthly Archives: November 2016

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.

FDA Consultants 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

NDC Number 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.

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.

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.

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.

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”.

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

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

Example DMF Drug Master File November 2, 2016

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