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.
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.
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.