Answers To Common Questions
Table of Contents
Answers
What is an electronic submission?
An electronic submission, is a submission composed and submitted in electronic media such as CD. It can be reviewed on a computer and all data sets can be conviently accessed on screen without delay. Contains similiar elements of a paper-based submission.
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What method do regulatory agencies refer, paper or electronic?
The FDA, as it transitions to the electronic format encourages companies to submit via the electonic medium. This reduces review times by assisting reviewers to easily navigate long volumious submissions, thus the referred format.
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How would our company benefit by submitting electronically?
Electronic submissions reduces time to market, reduces the number of questions asked by reviewers, reduces costs, decreases errors due administrative errors and finally, the ability to gain an edge-up on the competition.
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How would our company get started?
Call eSubmission Tech before embarging on an electronic submission to ensure all appropriate electronic guidelines are followed. Failure to do so, could result in a "Refusal to File" by the FDA.
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Would our company be required to buy an specific software?
No, your company may not be required to buy additional software for the compilation of electronic submissions.
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Our company has regulatory documentation in the paper format, is this a problem?
Half paper and half electronic submissions are acceptable. There is no need to commit to a paper submission if initiated in that medium.
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Our company plans on launching internationally, can we submit electronically?
Yes, the eCTD is intended to standardize electronic submissions and elements within a submission to various international countries.
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Will submitting electronically prolong the review period?
Many may believe that because the electronic format is relatively new to the industry, it will result in extended review period, however this is a misconception. Regulatory agencies have been working diligently toward this medium for a long time and encourage companies take advantage of the efficient and faster electronic product registration process.
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Is the FDA ready to accept electronic submissions?
Currently, only certain branches of the FDA are capable of accepting electronic submissions, they are CDER and CBER. CDRH is in the process of establishing processes needed for electronic submission and will be on-line in the near future.
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Is submitting via electronis medium expensive?
Electronic submissions can be time consuming, lenghty and expensive, however by consulting with eSubmission Tech early in the product development, we can tailor an electronic strategy that will dramatically reduce costs.
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