Services platform
Ensuring document compliance
"eCTD-read" source documents
This activity deals with ensuring source document compliance by taking into account an ever growing number of mandatory technical requirements.
Ensuring document compliance is one of the most fastidious, time and resource-consuming tasks.
Most of the time, this entails correcting source documents in pdf format with respect to quality, which could turn out to be very complicated or even impossible without a dedicated tool.
Thanks to its technical resources, ProductLife Group ensures the effectiveness and quality of these modifications.
This activity becomes essential for company documents originally prepared for paper dossier submissions.
Making documents eCTD-ready can be significantly improved by using streamlined templates, completed by a word-specific toolbar.
List of corrective actions performed
This activity may include the following actions:
- Digitization of documents available only in paper format. This digitization is realized according to defined parameters and using dedicated tools, in order to produce optimal digitized files.
- Reuse of existing documents in digitized form: clearing, optimization of file size ...
- OCR of pdf formated documents:
a. for already digitized documents
b. for other electronic documents coming from a prior digitization (e.g. legacy documentation)
- Creation or modification / complement / correction of the hyperlinks and bookmarks of pdf documents in order to make these documents eCTD compliant (example: pdf document coming from a Word document, but without navigable table of contents and their associated bookmarks).
- Optimization of existing documents in order to make them "eCTD compliant" in relation to Acrobat characteristics (file opening options, type of hyperlinks and bookmarks, version of the pdf file...)
- These actions are always preceded by a control on each document against an internal checklist.
- These actions are always followed by a validation phase against an internal checklist.
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Exhibition in Copenhagen: Join us at the 24th DIA Euromeeting
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Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
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Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
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