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what you should know about GDUFA II April 19, 2017

In the month of August  FY 2018 fees for generic drug application will be published,  which will be based on GDUFA II. We have summarized highlights  of GDUFA II fee structure and how it will benefit small business.  GDUFA II Highlights   No fees for  ANDA supplement fees No facility fees for manufacturing  facilities with … Continue reading what you should know about GDUFA II .... Read More

U.S Agent Terms and Condition March 27, 2017

Pragmatic is private consulting firm and offers U.S Agent services to many companies. Pragmatic is not affiliated with FDA. By accepting this agreement, Pragmatic and Company agree to following terms. Company means the receiving party of services Pragmatic is acting as U.S Agent for Company to facilitate the communication between  FDA (US Food and Drug … Continue reading U.S Agent Terms and Condition .... Read More

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

eCTD ! From the beginning of  May 5, 2017,  FDA requires, ANDA, NDA, and Master Files regulatory submission in eCTD  format. 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 submission in electronic format. … Continue reading FDA’s Mandatory eCTD requirements ? Are you ready ? .... Read More

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