Ensuring technical PDF compliance for eCTD submissions is complex and very time-consuming.
A lot of companies still manually manipulate PDFs to prepare for FDA, EMA, PMDA, HC, SwissHealth and other health authorities.
Manual work introduces compliance risks.
Compliant PDF creation, automatically checking and fixing Word and PDF documents
for global eCTD submissions can be fully automated.
DocShifter software checks and fixes Word documents, creates fully compliant PDFs and validates them for all your eCTD submissions
no matter where your content resides (RIM, eDMS or other)
This reduces manual work, risk of non-compliance and speeds up time to market.