Services to Ease FDA Regulatory Compliance

FDA’s Mandatory eCTD requirements ? Are you ready ?

25

Feb

2017

ectd requirements
ECTD

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 submission in electronic format.

Handling regulatory submission in electronic  format requires  trained professionals and software for  XML conversion. Moreover, eCTD submission is challenging  process considering FDA’s eCTD  validation requirements.

Electronic regulatory  submission involves  systematic  planing , document structuring  and complying to various requirements. eCTD publishing is crucial work since  small mistake may lead to refusal to recieve submission.

We at Pragmatic  offer complete solution for  eCTD publishing   of ANDA, NDA and all types of drug  master files including submission  through  our ESG account.   Unlike other companies we just do not convert your submission to eCTD , but we will also assist you locate the documents within  proper sections of eCTD.

Our regulatory experts have in depth knowledge and experience  in handling electronic submissions , with our services you need not to worry about document format, XML conversion or even templates for amendment, annual report or any such regulatory submission, We offer electronic submission services for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs), and master files at competitive fees with highest quality services.

Our  fees for  eCTD publishing  starts from as low as $ 329 which depends on the type of application and regulatory submission. Please contact us for more information.

Why Pragmatic  ?

With our services you will get one stop solution for all your regulatory requirements such as US agent service, establishment registration, NDC number, GDUFA self identification, gap analysis   or any other regulatory consulting services. Our services include complete support till acceptance of your regulatory application.

BACK

Translate »