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FDA Establishment Registration Fees March 11, 2017

Our  FDA establishment registration fees is $ 299 there is no hidden . Our services include complete assistance for the following. Assistance for obtaining DUNS number Creating establishment registration Submission of establishment registration to FDA through our ESG Assistance for obtaining FEI number Complete assistance till establishment  registration appears on FDA website. We offer guaranteed … Continue reading FDA Establishment Registration Fees .... Read More

How to market food products in US March 8, 2017

In order to market food products you have comply following requirements. 1, Foreign companies  required  to appoint US agent 2. Establishment Registration 3. Labelling 4. GMP manufacturing 5. Prior import notice Pragmatic can offer you all guidance and required services at lowest fees with quick turn around time. Contact us for more information.  .... Read More

FDA’s Mandatory eCTD requirements ? Are you ready ? February 25, 2017

From the beginning of  May 5, 2017,  FDA requires, ANDA, NDA, and Master Files regulatory submission in eCTD format. Link to FDA’s eCTD submission requirements Since FDA is mandating electronic submission  requirements from May 5, 2017 for all the  future amendments, annual reports , supplements or any such regulatory filings. But, its not mandatory to convert all previous … Continue reading FDA’s Mandatory eCTD requirements ? Are you ready ? .... Read More

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

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