One option is to change publishing vendor to one that has a viewer as part of the service. I have looked at viewers in the past and did not find any reasonably priced that would provide a view of an entire file (all compiled modules), but only by sequence. The service provider we use includes a viewer where I can review a sequence while it is being built and see every submission for the whole IND/NDA. And, it is not more expensive than a previous service provider who only provided the sequence after it was published.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 28-Feb-2019 13:34
From: Beth Weinberg
Subject: eCTD Storage and Viewer
I have recently joined a small start up where we have an outside vendor compile, publish and submit our eCTD files to FDA. Following submission they are returned to us for filing/storage. Can anyone recommend an affordable, easy to access eCTD viewer system that we can buy off the shelf? I have a quote from the same vendor we are using for our eTMF, but it seems high to me. For example, to be able to have a file structure by sequence, it is an extra $xx/month - the default is strictly by module. Appreciate any advice and direction!
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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
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