eCTD MS WORD & PDF FORMATTING

When publishing PDF files, it is important to consider the MS Word and PDF specifications guidance. These best practices come from recommendations from the ICH

PDF PUBLISHING

We take great care to follow industry guidance on PDF specifications when publishing PDF files, in order to meet the maximum efficiency for every submission. These best practices come from recommendations by the ICH and regional regulatory authority, and are essential for a successful submission that avoids technical rejection. By adhering to these standards, we can ensure that our PDF files meet the highest quality standards.

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MS WORD FORMATTING

Any document that is being prepared for eCTD submission must be formatted correctly. Ensuring margins, font sizes, cross referencing, tables are present. Without a pre-defined Word template to work from, this can be a very time-consuming task. At ONIX, we have years of experience formatting MS Word documents for eCTD submission.

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