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XML backbone based eCTD Documents

BayBiotech.NET

The eCTD submission requires construction of XML based backbone for the submission with strict guidelines for file name size, pdf style and hypertexting format. Although the XML based backbone is a choice for submission as it gives an advantage by making the submission independent of operating system environment, but also imposes some issues for a successful submission. In order to avoid the pitfalls and delay in response of obtaining RTF (refuse-to-file) along with the expertise in preparing high quality .pdfs for submission and expertise in XML is also required.

On analyzing the various tools available in the market, my recommendation will be to use caution in using such tools without double checking the submissions and having an independent quality check of your own as such tools are still at prelim phases of development and as a sponsor you may not wish to bet your million dollar investment on a RTF.

A good quality .pdf, an accurate XML coding as well as strictly following the eSubmission guidelines will be the key to success and you as a sponsor must be ready to invest in training your staff much ahead of time to gain success in future submissions.

The link here shares the experience of a small biotech in order to make you understand the relevance of a high quality preparation for eCTD Gateway: http://www.entrepreneur.com/tradejournals/article/175407584.html

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